FDA (Devices) recall action 98109
The FDA (Devices) publishes a recall like this one as 16 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 16 pages.
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
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 Medical Systems Nederland is recalling 22 units of the Allura Xper FD10/10, model 722027, because the drip tray beneath the cooling unit may not have been installed.
Philips Medical Systems Nederland is recalling 8 units of the Allura Xper FD20/20, model 722038, because the drip tray beneath the cooling unit may not have been installed.
Philips Medical Systems Nederland is recalling 18 units of the Allura Xper FD20 Biplane, model 722008, because the drip tray beneath the cooling unit may not have been installed.
Philips Medical Systems Nederland is recalling 2 Allura Xper FD20 systems because the drip tray beneath the cooling unit may not have been installed.
Philips Medical Systems Nederland is recalling 95 units of the Allura Xper FD10, model 722026, because the drip tray beneath the cooling unit may not have been installed.
Medline is recalling 338 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
Canon Medical Systems is recalling 34 Vantage Galan 3T MRI systems because ice may form in the venting system, and a quench in that condition could rupture the helium vessel.
Philips Medical Systems Nederland is recalling 21 units of the Allura Xper FD10/10, model 722011, because the drip tray beneath the cooling unit may not have been installed.
Philips Medical Systems Nederland is recalling 4 units of the Allura Xper FD20 OR Table, model 722023, because the drip tray beneath the cooling unit may not have been installed.
Medline is recalling 11173 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
Philips Medical Systems Nederland is recalling 143 units of the Allura Xper FD20, model 722006, because the drip tray beneath the cooling unit may not have been installed.
Philips Medical Systems Nederland is recalling 14 units of the Allura Xper FD10/10, model 722005, because the drip tray beneath the cooling unit may not have been installed.
Philips Medical Systems Nederland is recalling 93 units of the Allura Xper FD10, model 722003, because the drip tray beneath the cooling unit may not have been installed.
Philips Medical Systems Nederland is recalling 38 Allura Xper FD10C systems because the drip tray beneath the cooling unit may not have been installed.
Philips Medical Systems Nederland is recalling 12 units of the Allura Xper FD10F, model 722002, because the drip tray beneath the cooling unit may not have been installed.
Philips Medical Systems Nederland is recalling 23 units of the Allura Xper FD20 Biplane, model 722013, because the drip tray beneath the cooling unit may not have been installed.