Z-1053-2019Class II

Urodiagnost, Product No. 708033

Name: Z-1053-2019 Urodiagnost, Product No. 708033
Creator: Philips North America, LLC
Published: 2019-02-28
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2019-02-28 / Terminated / root cause: design

FDA source

Philips North America, LLC began a recall of Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine examinations... on 2019-02-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1053-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-28
Posted: 2019-03-23
Terminated: 2020-08-03
Recalling firm: Philips North America LLC
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
Product code: IXR Table, Radiographic, Tilting
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 1969
Distribution: US Nationwide domestic distribution, and worldwide international distribution.
Product codes and lots: Serial codes 1 2 3 4 5 7 8 11 13 14 15 16 17 18 21 48 59 60 64

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1053-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1052-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-23
Z-1053-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-23
Z-1054-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-23
Z-1055-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-23
Z-1056-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-23

Product code IXR

K911098Class IIPhilips Uro Diagnost MrfPhilips Medical Systems, Inc. / cleared 1991-07-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)