FDA Medical Device Recalls (openFDA)
Medstone International Inc: URO PRO Plus Digital Urology Imaging System
- Recall number
- Z-0162-04
- Recalling firm
- Medstone International Inc
- Product
- URO PRO Plus Digital Urology Imaging System
- Status
- Terminated
- Initiated
- 2003-08-11
- Posted
- 2004-07-20
- Terminated
- 2003-11-26
- Reason
- X-ray tube arm and collimator fell and fractured patient's ribs.
- 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
- 5 units
- Distribution
- NM, NV, WA, CA.
- Lot, serial or model codes
- Serial Numbers: UR2003-006 UR2001-006 UR2002-010 UR2003-004 UR2001-2R03
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 2082981
- Firm city
- Aliso Viejo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28