CIVCO MTAPSID2932 Type-S Thermoplastic, Disposable nonsterile (48.3 cm) IMRT Style 29 thermoplastic (3.2 mm), Ref. MTAPS
FDA device recall Z-0124-2010 · posted 2009-11-06 · Terminated
Recall details
- Recalling firm
- Med Tec Inc
- Reason for recall
- Some of the packages contain the incorrect mask style.
- Action taken
- The recalling firm initiated their recall via letter dated 8/27/09 issued certified mail for the domestic customers and e-mail for the foreign customer. The communication informs the customer of the reason for recall and offers to replace the product. For questions or for return of the mask, a phone number is provided. A response form was enclosed with the letter for completion to indicate the amount of affected product in the possession of the customer and whether or not they plan to return it.
- Root cause
- Process control
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 12 boxes
- Distribution
- Worldwide Distribution -- USA, including states of FL, TX, and OH and country of Australia.
- Date initiated
- 2009-08-31
- Date posted
- 2009-11-06
- Date terminated
- 2012-03-07
- Location
- Orange City, IA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNI-FRAME HEAD IMMOBILIZATION SYSTEM (K933227) | Medtec, Inc. | 1994-07-18 |