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65 catalysts · 25 device recall · 21 recall · 14 device 510k · 5 device pma
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65 catalysts · 25 device recall · 21 recall · 14 device 510k · 5 device pma
Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311. — Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. — Status: Ongoing
Product code: GXY. Advisory committee: Neurology. Type: Traditional
Product code: QBN. Advisory committee: Microbiology. Type: Traditional
Product code: PZL. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HEB. Advisory committee: Obstetrics/Gynecology. Type: Special
Product code: BTR. Advisory committee: Anesthesiology. Type: Traditional
Product code: NQJ. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: QRA. Advisory committee: Neurology. Type: Traditional
Product code: FAJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: DZL. Advisory committee: Dental. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Special
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: GAT. Advisory committee: General, Plastic Surgery. Type: Special