Block Mold Cutter, Model 8532, Version 1.2.
FDA device recall Z-0985-02 · posted 2003-09-13 · Terminated
Recall details
- Recalling firm
- Multidata Systems Intl Corp
- Reason for recall
- The units lacked the required labels per the laser performace standard.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 10 units
- Distribution
- Distribution was made to SC, FL, GA, NY, PA, NC, IL, and NJ.
- Date initiated
- 2002-11-10
- Date posted
- 2003-09-13
- Date terminated
- 2003-12-12
- Location
- St Louis, MO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY) (K964167) | Multidata Systems International Corp. | 1997-03-21 |