Fiducial Markers (0.9 x 3 mm) Soft tissue gold markers, Medical charged-particle radiation therapy system; Part Number:
FDA device recall Z-1614-2008 · posted 2008-05-21 · Terminated
Recall details
- Recalling firm
- Med Tec Inc dba CIVCO Medical Solutions
- Reason for recall
- Mislabeled: Fiducial markers were incorrectly labeled. They are marked (0.9x3mm cylindrical) Soft tissue gold markers, but contain (2mm spheres) Bone gold markers.
- Action taken
- Consignees were notified via telephone beginning 2/28/08 and a Recall Notification letter sent on 2/29/08. Users were requested to return any affected products for a replacement. They were also requested to return a recall notification form indicating the amount of affected product in their inventory. For additional information, call 800-842-8688.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 33/3-marker pouches
- Distribution
- Nationwide Distribution including states of WA, PA, DE, AL, CT, WI, FL, TX, MN, and IL.
- Date initiated
- 2008-02-28
- Date posted
- 2008-05-21
- Date terminated
- 2008-07-02
- 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 |
|---|---|---|
| FIDUCIAL MARKERS (K071614) | Civco | 2007-09-11 |