Z-0162-04

URO PRO Plus Digital Urology Imaging System

Name: Z-0162-04 URO PRO Plus Digital Urology Imaging System
Creator: Medstone International Inc
Published: 2003-08-11
License: https://open.fda.gov/license/

Medstone International Inc / initiated 2003-08-11 / Terminated

FDA source

Medstone International Inc began a recall of URO PRO Plus Digital Urology Imaging System on 2003-08-11. The reason FDA records is "X-ray tube arm and collimator fell and fractured patient's ribs". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0162-04
Status: Terminated
Initiated: 2003-08-11
Posted: 2004-07-20
Terminated: 2003-11-26
Recalling firm: Medstone International Inc
Product: URO PRO Plus Digital Urology Imaging System
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: X-ray tube arm and collimator fell and fractured patient's ribs.
FDA root cause: Other
Action: An initial safety alert was sent to sites on 7/29/2003 to pre-announce repairs and advise them to not use the equipment. A second safety alert was sent on 8/11/03 to confirm repair dates. Repairs were completed 8/19,2003.
Quantity in commerce: 5 units
Distribution: NM, NV, WA, CA.
Product codes and lots: Serial Numbers: UR2003-006 UR2001-006 UR2002-010 UR2003-004 UR2001-2R03

Product code JAA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)