—#171335

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

FDA product code: IXR — Table, Radiographic, Tilting
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K911098
Affected lot / code info: Serial codes 1 2 3 4 5 7 8 11 13 14 15 16 17 18 21 48 59 60 64

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

On February 28, 2019, the firm notified customers via an Urgent Field Safety Notice letter. The letter informed customers that the affected systems would be inspected for missing locking plates. Customers were asked to place a copy of the Field Safety Notice with the documentation of the system until the system has been inspected by Philips. Philips will inspect all potentially affected systems free of charge. If a locking plate is found missing, Philips will secure the system until a locking plate is installed so that use of the system can continue. You will be contacted by your local Philips representative to schedule the inspection. Philip's action will start effective from March 2019. If you need further information or support concerning this issue, please contact your local Philips representative.

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

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

Timeline

Recall initiated: 2019-02-28
Terminated: 2020-08-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171335. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.