FDA recall Z-1053-2019

Philips North America, LLC · Class II · 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

Reason for recall

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.

Distribution

US Nationwide domestic distribution, and worldwide international distribution.

Key facts

Status
Terminated
Initiation date
2019-02-28
Report date
2019-04-03
Termination date
2020-08-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1053-2019