CLASS II Device recall · Reported 3 Apr 2019 · FDA Enforcement Report

Urodiagnost, Product No. recalled by Philips North America

Philips North America is recalling Urodiagnost, Product No. 708033, distributed nationwide in the US. The recall was initiated on 28 Feb 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial codes 1 2 3 4 5 7 8 11 13 14 15 16 17 18 21 48 59 60 64

Quantity recalled1969

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1053-2019
FDA event ID: 82313
Recalling firm: Philips North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 28 Feb 2019
FDA classified: 23 Mar 2019
Reported: 3 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

28 Feb 2019	Recall initiated by company
23 Mar 2019	Classified by FDA	+23 days
3 Apr 2019	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

US Nationwide domestic distribution, and worldwide international distribution.

Nationwide

Questions about this recall

Why was it 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.

Which lots are affected?

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

Where was it sold?

US Nationwide domestic distribution, and worldwide international distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 82313

This product is part of a recall event; the main page for the event is MultiDiagnost-Eleva, Product codes recalled by Philips North America.

Reported	Class	Recall	Company	Reason	Where
3 Apr 2019	CLASS II	MultiDiagnost-Eleva, Product codes recalled by Philips North America	Philips North America	Other	Nationwide
3 Apr 2019	CLASS II	Omnidiagnost Classic, Product Codes 70859 recalled	Philips North America	Other	Nationwide
3 Apr 2019	CLASS II	MultiDiagnost Eleva w/ Flat Detector, Product codes recalled	Philips North America	Other	Nationwide
3 Apr 2019	CLASS II	URODiagnost Eleva, Product codes recalled by Philips North America	Philips North America	Other	Nationwide

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