Device product

DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052

Z-2865-2018

June 27, 2018

Class II

Product summary

Firm: Philips Medical Systems Gmbh, DMC
Event: Event 80577
Status: Terminated
Classification: Class II
Quantity: Unavailable
Official record key: device-enforcement:Z-2865-2018

Official wording

Reason: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information: Serial Numbers: 363679 404164/SN0802462 378830/SN0802004 341693 358494 359442 396571/SN0802311 359449 346075 382021/SN0802313 374374 404298/SN0802474 402570/SN0802420 373501 373500 382272/SN0802113 368428 382012/SN0702520 376667 356957 392502/SN0802179 407423/SN0802638 359767 368619 358641 357697 381998/SN0702488 413829/SN0802631 358320 400364/SN0802522 404166/SN0802441 356981 390272/SN0802364 390273/SN0802366 412482/SN0802683 348997 396576/SN0802233 372848 373508 383084/SN0802127

Distribution pattern: US Nationwide; International to 66 countries

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.