The Recall Desk

Hazard

Firmware Defect recalls

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

What the numbers show

Total
36
Critical
6
Severe
0
Most recent
2026-08-26

Of the 36 firmware defect recalls we have scored against our rubric, 6 (17%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all firmware defect 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.

26–36 of 36

  • HighFDA (Devices)·Z-1120-2020·2020-02-19

    Flowonix Prometra Programmable 20mL Pump Recalled for Firmware Alarm Anomaly

    Flowonix Medical Inc is recalling Prometra Programmable 20mL Pumps because a firmware anomaly may prevent the device from sending error notifications or audible alarms during valve system issues.

    Product
    Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1101-2019·2019-05-01

    KaVo Orthopantomograph OP 3D Cone-Beam CT System Firmware Recall

    KaVo Dental Technologies is recalling 230 Orthopantomograph OP 3D cone-beam CT systems due to a defect in firmware versions 2.1.0 and 2.1.1.

    Product
    cone-beam CT system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1930-2018·2018-05-30

    Siemens Biograph Horizon PET/CT Systems Recalled for Firmware Issue

    Siemens Medical Solutions is recalling 14 Biograph Horizon PET/CT systems due to a firmware issue that may cause waveform sampling errors during cardiac gating examinations.

    Product
    Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1208-2018·2018-04-04

    Puritan Bennett 980 Ventilator Batteries Recalled for Firmware Defect

    FDA is recalling 15,885 rechargeable lithium-ion batteries for Puritan Bennett 980 ventilators due to incorrect firmware that may prevent full charging.

    Product
    Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3070-2017·2017-09-06

    Toshiba Ultimax Digital Fluoroscopic X-Ray System Recalled for Firmware Issue

    Toshiba is recalling 18 Ultimax Digital Fluoroscopic X-Ray Systems due to a firmware problem with the generator.

    Product
    Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy. The system has medical applications ranging from but not limited to: contrast-e
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-2629-2016·2016-08-31

    GE OEC 9800 Fluoroscopic X-Ray System Recalled for Monitor Firmware Issue

    GE OEC Medical Systems is recalling 47 OEC 9800 fluoroscopic x-ray systems because a firmware issue may cause the LCD workstation monitors to appear dark with no video displayed.

    Product
    OEC 9800, fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2605-2016·2016-08-31

    Panacea Air Pro Mattress Control Unit Recalled for Firmware Issue

    American National Mfg Inc is recalling 31 Panacea Air Pro Mattress Control Units due to a firmware problem that may affect the device's firmness range.

    Product
    Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0199-2013·2012-11-28

    GE Healthcare Recalls Mobile Radiographic Units Due to Firmware Issue

    GE Healthcare is recalling specific mobile radiographic units due to a firmware issue affecting technique accuracy as mandated by federal regulations.

    Product
    GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0198-2013·2012-11-28

    GE Healthcare Recalls Mobile Radiographic Imaging Systems Due to Firmware Issue

    GE Healthcare is recalling specific mobile radiographic imaging systems due to a firmware issue affecting technique accuracy as mandated by regulations.

    Product
    GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0197-2013·2012-11-28

    GE Healthcare Recalls Mobile Radiographic Systems Due to Firmware Issue

    GE Healthcare is recalling specific mobile radiographic systems due to a firmware issue affecting technique accuracy.

    Product
    GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0200-2013·2012-11-28

    GE Healthcare Recalls Mobile Radiographic Imaging Systems Due to Firmware Issue

    GE Healthcare is recalling Brivo XR 285 and Optima XR series mobile radiographic systems due to a firmware issue affecting technique accuracy.

    Product
    GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.
    Category
    Medical Device
    Distribution
    Distributed nationwide