Medstone International Inc URO PRO Plus Digital Urology Imaging System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
URO PRO Plus Digital Urology Imaging System
Brand
Medstone International Inc
Lot Codes / Batch Numbers
Serial Numbers: UR2003-006 UR2001-006 UR2002-010 UR2003-004 UR2001-2R03
Products Sold
Serial Numbers: UR2003-006 UR2001-006 UR2002-010 UR2003-004 UR2001-2R03
Medstone International Inc is recalling URO PRO Plus Digital Urology Imaging System due to X-ray tube arm and collimator fell and fractured patient's ribs.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
X-ray tube arm and collimator fell and fractured patient's ribs.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, NV, NM, WA
Page updated: Jan 10, 2026