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Recall Observatory FDA recall evidence

Device product

Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine examinations including: Urograms with injection or infusion Retrograde pyelography Cystography and urethrography Micturition cystography Cystoscopy, endopscopy Transurethral resection Percutaneous nephroscopy Urethrorenoscopy Percutaneous nephrolithotomy Serial angiography with image intensifier and DSI Tomography

Z-1053-2019

February 28, 2019

Class II

Product summary

Firm
Philips North America, LLC
Event
Event 82313
Status
Terminated
Classification
Class II
Quantity
1969
Official record key
device-enforcement:Z-1053-2019

Official wording

Reason: The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.

Code information: Serial codes 1 2 3 4 5 7 8 11 13 14 15 16 17 18 21 48 59 60 64

Distribution pattern: US Nationwide domestic distribution, and worldwide international distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.