Hazard

Software Error recalls

102 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all software error recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

76–100 of 102

HighFDA (Devices)·Z-0832-2022·2022-04-06
Ambulatory infusion pumps recalled due to erroneous software installation
InfuTronix is recalling Nimbus PainPro ambulatory infusion pumps after an unreleased software version was installed in error. The defective units may impact patient safety.
Product
Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0749-2022·2022-03-23
Abbott Alinity s System software error affects diagnostic analyzer wash cycle
Abbott Laboratories is recalling 306 units of Alinity s System software version 2.8.0 due to a software error causing insufficient wash buffer volume, which could affect diagnostic test accuracy.
Product
Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specifi
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·22V151000·2022-03-11
2021-2022 Ford Edge Rearview Camera Software Error Causes Display Failure
Ford is recalling 2021-2022 Edge vehicles with a software error that may cause the rearview camera to display a blank or distorted image. This reduces driver visibility behind the vehicle, increasing crash risk.
Product
FORD — 2021 FORD EDGE
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0402-2022·2021-12-29
Nurse Call Communication System Components May Fail to Reboot
Hill-Rom's NaviCare and Voalte nurse call communication systems may experience an unrecoverable software error causing components to fail reboot cycles and become non-functional, requiring replacement.
Product
These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Product was rebranded from NaviCare to Voalte in 2020
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0282-2022·2021-12-01
Medtronic Cardiac Device Software Affected by Data Processing Error
Medtronic is recalling software used in certain cardiac implant devices due to a data processing error that may fail to collect episode data. Approximately 18,715 devices are affected worldwide.
Product
Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds): Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0200-2022·2021-11-10
Artis zeego X-Ray System Software Error Affects Image Reconstruction
Siemens Artis zeego fluoroscopic X-ray systems have a software error that incorrectly displays 3D image reconstruction when the patient table is rotated more than 4 degrees, potentially resulting in incorrect patient treatment during image-guided procedures.
Product
Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0174-2022·2021-11-03
Xstrahl Concerto Software Fails to Update Opposing Beam Treatment Parameters
Xstrahl's Concerto software used in X-ray therapy systems may fail to update treatment parameters for a second beam when a treatment plan is edited. This could result in error messages and incorrect treatment delivery.
Product
Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Therapy System; (2) Xstrahl 150 Electronic Brachytherapy - 150kV Superficial X-Ray Therapy System; (3) Xstrahl 200 - 225kV Superficial / O
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0123-2022·2021-10-27
Philips EPIQ CVxi Ultrasound Systems Software Issue Causes System Unresponsiveness
Philips EPIQ CVxi ultrasound systems running software versions 6.0, 7.0, or 7.0.3 may become unresponsive due to an EchoNavigator error, requiring system restart that could delay treatment.
Product
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-2438-2021·2021-09-15
Solero MTA Generator refurbished units require software servicing
Eight refurbished Solero MTA Generator units require software upgrades to reduce startup errors occurring in specific serial numbers.
Product
Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2436-2021·2021-09-15
Solero MTA Generator requires software upgrade for startup error
Angiodynamics is recalling specific refurbished Solero MTA Generators due to Error 0001, which occurs during system startup. A software upgrade is required to reduce the error's frequency.
Product
Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2437-2021·2021-09-15
Solero MTA Generator Requires Software Upgrade to Reduce Startup Error
Angiodynamics is servicing specific Solero MTA Generator units to upgrade the software and reduce Error 0001 during startup. Affected units are identified by serial number.
Product
Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2399-2021·2021-09-08
DePuy TruMatch CT Cut Guide Kit Recalled for Software Alignment Error
DePuy's TruMatch CT Cut Guide Kit is being recalled due to a software coding error that may cause misalignment of preoperative surgical positioning scans, potentially resulting in improper limb alignment during joint replacement surgery.
Product
TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2395-2021·2021-09-08
Surgical instrument software error may cause limb misalignment
DePuy Orthopaedics' TruMatch CT Pin Guide Kit has a software coding error that may misalign bone landmarks during joint replacement surgery, potentially causing limb malalignment. No injuries have been reported.
Product
TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2394-2021·2021-09-08
CT Pin Guide Instruments Recalled for Software Imaging Alignment Error
The TruMatch CT Pin Guide Kit is being recalled due to a software error that may misalign surgical guidance images, potentially affecting limb positioning during hip, knee, and ankle surgery. No injuries have been reported.
Product
TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2396-2021·2021-09-08
Surgical alignment software error recalled in patient-specific orthopedic instruments
DePuy Orthopaedics recalls TruMatch surgical instruments due to a software error in the scanning alignment tool that may cause incorrect limb positioning during surgery.
Product
TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2397-2021·2021-09-08
TruMatch Surgical Instruments Recalled for Software Alignment Error
DePuy Orthopaedics recalls TruMatch patient-specific surgical instruments due to a Fast3D software error that may misalign scanning images, potentially causing limb malalignment during surgery.
Product
TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2387-2021·2021-09-08
Merge Hemo Software Recall Due to HL7 Lab Interface Safety Issue
Merge Healthcare recalls Merge Hemo software versions 10.2, 10.3, and 10.4. The safety issue affects versions 9.x and 10.x when used with HL7 lab interfaces. No illnesses or injuries reported.
Product
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2404-2021·2021-09-08
Siemens Artis Angiography Systems Software Error May Delay Clinical Treatment
Certain Siemens Artis angiography systems with software version VD12 may fail to start up properly due to a software error, potentially delaying clinical imaging procedures. The issue affects specific units identified by serial number.
Product
Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2400-2021·2021-09-08
TruMatch CT Surgical Guidance Software Misalignment in Joint Replacement Instruments
DePuy Orthopaedics' TruMatch CT surgical instrument system has a software coding error that may prevent proper alignment of scanning images, potentially causing limb malalignment during joint replacement surgery.
Product
TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2398-2021·2021-09-08
Medical Device Recall: TruMatch CT Cut Guide Kit Software Misalignment Error
DePuy Orthopaedics is recalling TruMatch CT Cut Guide Kits due to a software coding error in the Fast3D Segmentation software that may cause improper alignment of anatomic images, potentially resulting in limb malalignment during surgery.
Product
TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2317-2021·2021-08-25
IQon Spectral CT System Software Error Increases Contrast Volume
Philips IQon Spectral CT systems can recommend excessive contrast volume when patient weight is set to pounds due to a SynchRight software calculation error, potentially resulting in patient overdose.
Product
728332 IQon Spectral CT-Computed Tomography X-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2316-2021·2021-08-25
CT system software error recommends excessive contrast volume
A software defect in Philips CT imaging systems causes incorrect contrast volume calculations when patient weight units are set to pounds, resulting in increased contrast dosing recommendations. Three units with specific serial numbers are affected.
Product
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2098-2021·2021-07-28
SoftCytogenetics Software Recalled for Incorrect Test Result Transmission
Soft Computer Consultants, Inc. is recalling SoftCytogenetics software (versions 4.1.11.20, 4.1.12.11, 4.1.15.6) distributed in CA, FL, MN, and NJ because it produces incorrect results for retested specimens that are transmitted to clinical information systems.
Product
SoftCytogenetics
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2014-2021·2021-07-14
ADVIA Chemistry XPT System Software May Report Incorrect Patient Test Results
Siemens Healthcare is recalling certain ADVIA Chemistry XPT systems with software version 1.4 or lower due to a default mixer failure detection setting that may allow incorrect patient lab results to be reported without alerting clinicians.
Product
The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for in
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1997-2021·2021-07-07
Tempus Pro Patient Monitor Software Error Risk When Unplugged
Remote Diagnostic Technologies is recalling Tempus Pro patient monitors (Trizeps 7 variant) that can produce error states when unplugged while connected to a specified laryngoscope device. No injuries have been reported.
Product
Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals lo
Category
Medical Device
Distribution
Distributed nationwide