URO PRO Plus Digital Urology Imaging System
FDA device recall Z-0162-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Medstone International Inc
- Reason for recall
- X-ray tube arm and collimator fell and fractured patient's ribs.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 5 units
- Distribution
- NM, NV, WA, CA.
- Date initiated
- 2003-08-11
- Date posted
- 2004-07-20
- Date terminated
- 2003-11-26
- Location
- Aliso Viejo, CA
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