FDA (Devices) recall action 97187
The FDA (Devices) publishes a recall like this one as 22 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 22 pages.
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned mainten…
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
GE SIGNA Hero XT MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
GE HealthCare is recalling 138 SIGNA Artist Evo MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling SIGNA Voyager AIR (China Only) MRI systems because a planned maintenance step checking the patient table caster locks may not have been performed.
GE SIGNA UHP MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. 3 units affected.
GE HealthCare is recalling 214 SIGNA Premier MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE Discovery MR750w 3.0T MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. 519 units affected.
GE HealthCare is recalling 151 SIGNA Architect AIR (China Only) MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling 330 Discovery MR750 3.0T MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling 1,372 Optima MR450w 1.5T MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE SIGNA Premier MAX MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
GE SIGNA Hero Elite MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
GE HealthCare is recalling 56 SIGNA Hero MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling SIGNA PET/MR AIR (China Only) systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE SIGNA Hero MAX MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
GE HealthCare is recalling SIGNA PET/MR AIR Plus (China Only) systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling 758 SIGNA Architect MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE SIGNA Premier XT MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. 2 units affected.
GE HealthCare is recalling 97 SIGNA PET/MR imagers because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling 760 Signa Artist MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling SIGNA Premier Elite (China Only) MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling 280 Signa Voyager MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling 19 Discovery MR450 1.5T MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.