Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-01-22FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IIGE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-01-22FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IIGE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-01-22FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IIGE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-01-22FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IIGE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-01-22FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IIGE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH; 5) H3100XB; System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-01-22FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IIGE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H3100BT; 5) H3100PX; System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-01-22FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IIGE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, 6) H3100JW, 7) H3100NC; System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-01-22FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IIGE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY; System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-01-22FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IIGE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-01-22FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IIGE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-01-22FDA-DeviceBaxter Healthcare CorporationClass IBreathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- 2025-01-22FDA-DeviceBaxter Healthcare CorporationClass IWelch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- 2025-01-22FDA-DeviceBaxter Healthcare CorporationClass IWelch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- 2025-01-22FDA-DeviceBaxter Healthcare CorporationClass IWelch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,FORCE BIPOLAR,IS4000 REF 471405
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,MEGA SUTURECUT ND,IS4000 REF 471309
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,COBRA GRASPER,IS4000 REF 471190
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,PROGRASP FORCEPS,IS4000 REF 471093
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,CADIERE FORCEPS,IS4000 REF 471049
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,LONG TIP FORCEPS,IS4000 REF 471048
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,FORCE BIPOLAR,IS4000 REF 470405
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
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