medical Class II Updated 2021-07-07

Philips North America Llc recalls Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Op

Recalled Product

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore

Hazard / Issue

Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model/ Serial Number/UDI: N/A 728242 20004 N/A 728242 768007 (01)00884838095168 728242 20013 N/A 728243 75107 N/A 728243 7729 N/A 728243 7786 N/A 728243 7741 N/A 728243 7820 N/A 728243 7892 N/A 728243 75027 N/A 728243 75029 N/A 728243 7941 N/A 728243 75047 N/A 728243 7467 N/A 728243 7831 N/A 728243 7831 N/A 728243 7560 N/A 728243 75067 N/A 728243 7689 N/A 728243 7442 N/A 728243 75111 N/A 728243 7927 N/A 728243 7558 N/A 728243 7769 N/A 728243 7284 N/A 728243 75066 N/A 728243 7905 N/A 728243 7800 N/A 728243 7724 N/A 728243 7946 N/A 728243 7385 N/A 728243 7192 N/A 728243 7211 N/A 728243 7891 N/A 728243 75041 N/A 728243 7269 N/A 728243 7064 N/A 728243 7116 N/A 728243 7214 N/A 728243 7795 N/A 728243 7701 N/A 728243 7810 N/A 728243 7743 N/A 728243 75064 N/A 728243 75120 N/A 728243 750005 N/A 728243 750013 N/A 728244 760014 (01)00884838059450(21)760014 728244 760013 (01)00884838059450(21)760013 728244 76230 N/A 728244 76259 (01)00884838059450(21)76259 728244 76238 (01)00884838059450(21)76238 728244 76147 (01)00884838059450(21)76147 728244 76178 (01)00884838059450(21)76178 728244 7764 N/A 728244 760045 (01)00884838059450(21)760045 728244 760023 (01)00884838059450(21)760023 728244 75123 N/A 728244 760047 (01)00884838059450(21)760047 728244 76109 (01)00884838059450(21)76109 728244 760056 (01)00884838059450(21)760056 728244 7653 N/A 728244 76249 (01)00884838059450(21)76249 728244 76228 (01)00884838059450(21)76228 728244 76299 (01)00884838059450(21)76299 728244 7926 N/A 728244 7533 N/A 728244 7917 N/A 728244 76095 (01)00884838059450(21)76095 728244 7874 N/A 728244 7452 N/A 728244 76113 (01)00884838059450(21)76113 728244 76140 (01)00884838059450(21)76140 728244 76078 (01)00884838059450(21)76078 728244 7781 N/A 728244 76079 (01)00884838059450(21)76079 728244 760015 (01)00884838059450(21)760015 728244 760029 N/A 728244 760011 (01)00884838059450(21)760011 728244 7694 N/A 728244 76248 N/A 728244 7747 N/A 728244 7773 (01)00884838059450(21)7773 728244 7826 N/A 728244 76290 (01)00884838059450(21)76290 728244 7915 N/A 728244 7721 N/A 728244 76268 (01)00884838059450(21)76268 728244 76177 (01)00884838059450(21)76177 728244 760003 (01)00884838059450(21)760003 728244 760004 (01)00884838059450(21)760004 728244 76214 (01)00884838059450(21)76214 728244 76250 (01)00884838059450(21)76250
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