Philips North America, LLC recalls Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gy…

Recall date

February 28, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1053-2019

FDA classification

Class II

Brand / firm

Philips North America, LLC

Sold / distributed

US Nationwide domestic distribution, and worldwide international distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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