FDA (Devices) recall action 74511
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack causing injury to patients, operators, by-standers and service personnel.
Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack and cause injury to patients, operators, by standers or service personnel.
Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack.
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.
Philips is recalling 10 Ingenuity Flex MRI units because a thinner plastic cover may crack, posing an injury risk to patients and staff.
Philips is recalling three Brilliance CT Big Bore Oncology scanners because a thinner plastic cover may crack and cause injury to patients or staff.
Philips is recalling 14 Ingenuity Core 128 MRI systems because a thinner plastic cover may crack, posing an injury risk to patients and staff.
Philips is recalling Brilliance iCT scanners because a design change resulted in a thinner plastic cover that may crack.
Philips Medical Systems is recalling Ingenuity Core MRI scanners because a thinner plastic cover may crack, posing an injury risk to patients and staff.