Recalls / —
—#49146
Product
Modularis URO urological table Model number 5531012
- FDA product code
- MMZ — Table, Cystometric, Electric
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K033335
- Affected lot / code info
- Model number 5531012, serial numbers 01001 to 01345
Why it was recalled
Potential pinch point with the patient table
Root cause (FDA determination)
Other
Action the firm took
The recalling firm has issued a Customer Safety Advisory to affected customers per Update Instructions SPO23/06/S. This letter, to be inserted in the system Operator Manual, reminds customers of the potential pinch point and provides a suggestion to avoid its occurrence.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406
Distribution
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2006-10-01
- Posted by FDA
- 2006-11-14
- Terminated
- 2008-05-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #49146. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.