FDA (Devices) recall action 89376
The FDA (Devices) publishes a recall like this one as 32 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 32 pages.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
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 Healthcare SIGNA HFO/I MR Systems may have cryogen ventilation systems that do not meet venting requirements. Approximately 17,228 systems are affected nationwide and internationally.
GE Healthcare is recalling 17,228 MRI superconducting magnets due to a potential cryogen ventilation system defect. The systems may not meet required venting specifications.
GE Healthcare is recalling MRI systems with potentially non-compliant cryogen ventilation. Over 17,228 superconducting magnetic resonance imaging devices may have cryogen venting systems that fail to meet FDA requirements.
GE Healthcare is recalling 17,228 MRI systems because the cryogen ventilation system may not meet venting requirements. The company is providing field corrections to ensure proper ventilation.
GE Healthcare is recalling 17,228 MRI system magnets with potential cryogen ventilation defects. No injuries have been reported.
GE Healthcare is recalling MR superconducting magnets used in SIGNA Voyager MRI systems due to cryogen ventilation systems that may not meet venting requirements. The recall affects 17,228 devices.
GE Healthcare is recalling 17,228 superconducting magnetic resonance imaging systems due to potential cryogen ventilation system defects that may not meet safety venting requirements.