Hazard

Safety Issue recalls

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

What the numbers show

Total: 17
Critical: 0
Severe: 0
Most recent: 2016-11-23

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

About this hazard tag

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

1–17 of 17

HighFDA (Devices)·Z-0608-2017·2016-11-23
Siemens Recalls CT Systems for Software Safety Bug Fixes
Siemens is recalling seven CT systems to install a software update that fixes bugs and corrects potential safety issues.
Product
SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at diff
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0607-2017·2016-11-23
Siemens Recalls CT Systems for Software Safety Bug Fixes
Siemens is releasing a software update for specific CT systems to correct potential safety issues and improve performance.
Product
SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at diffe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2878-2016·2016-10-05
Siemens Syngo RT Therapist Software Recalled for Safety Issues
Siemens Medical Solutions is recalling Syngo RT Therapist software to address several safety issues. The recall affects 103 linear accelerators nationwide.
Product
Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positionin
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2876-2016·2016-10-05
Siemens ARTISTE Linear Accelerators Recalled for Software Safety Issues
Siemens Medical Solutions is recalling 103 ARTISTE linear accelerators to install a software patch addressing several safety issues.
Product
ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2877-2016·2016-10-05
Siemens PRIMUS Linear Accelerators Recalled for Software Safety Issues
Siemens Medical Solutions is recalling 103 PRIMUS linear accelerators to install a software patch addressing several safety issues.
Product
PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0524-2014·2013-12-25
GE Recalls InstaTrak and ENTrak Computer-Assisted Navigation Systems
GE OEC Medical Systems is recalling InstaTrak and ENTrak navigation systems due to potential safety issues.
Product
InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1959-2013·2013-08-21
GE Healthcare Recalls Disposable Temperature Probes Due to Safety Concerns
GE Healthcare is recalling disposable temperature probes due to a potential safety issue with esophageal placement.
Product
Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1182-2013·2013-05-08
Siemens Medical Solutions Recalls RT Therapist Software for Safety Issues
Siemens Medical Solutions is recalling RT Therapist software versions 4.2.108 to fix multiple safety-related issues on linear accelerator systems.
Product
Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation fo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1036-2013·2013-04-10
Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions for Primus and Oncor linear accelerators to address performance defects and safety issues.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG TH, Part No. 5863506, Current R630; Product Usage: The intended use of
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1043-2013·2013-04-10
Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions for linear accelerators to address multiple performance defects and safety issues.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.1, Part No. 8147675, Current R640; Product Usage: The intended us
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1044-2013·2013-04-10
Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Performance Defects
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and safety issues that were not considered critical for immediate correction.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.0, Part No. 8139847, Current R630; Product Usage: The intended us
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1038-2013·2013-04-10
Siemens COHERENCE RT Therapist Software Recall for Performance Defects
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions to address performance defects and non-critical safety issues identified during final system testing.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE Impression TH, Part No. 7341410, Current R630; Product Usage: The intend
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1037-2013·2013-04-10
Siemens COHERENCE RT Therapist Software Recall for Safety Defects
Siemens is recalling COHERENCE RT Therapist software versions for Primus and Oncor linear accelerators to address performance defects and safety issues.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH, Part No. 7339125, - Current R630; Product Usage: The intended use of
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1039-2013·2013-04-10
Siemens COHERENCE RT Therapist Software Recalled for Performance Defects
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical safety issues.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.0, Part No. 8139839, Current R630; Product Usage: The intended us
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1042-2013·2013-04-10
Siemens COHERENCE RT Therapist Software Recall for Performance Defects
Siemens is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical safety issues identified during final system testing.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i, Part No. 7341428, Current R610/R630; Product Usage: The intended us
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1040-2013·2013-04-10
Siemens COHERENCE RT Therapist Software Recall for Performance Defects
Siemens is recalling COHERENCE RT Therapist software versions to address performance defects and safety issues identified during final system testing.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.1, Part No. 8147667, Current R640; Product Usage: The intended use
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1041-2013·2013-04-10
Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical safety issues identified during final system testing.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.2, Part No. 10568431, Current R640; Product Usage: The intended use
Category
Medical Device
Distribution
0 states