MT-APSD-2.4 Type-S Thermoplastic Mask, Medical charged-particle radiation therapy system; Disposable non-sterile (43.2cm
FDA device recall Z-1608-2008 · posted 2008-05-21 · Terminated
Recall details
- Recalling firm
- Civco Medical Instruments Inc
- Reason for recall
- Mislabeled: The mask is mislabeled with the incorrect part number but the outer packaging is correct.
- Action taken
- Consignees were notified by a Recall Notification letter on 2/25/08. The letter informed users that the recalling firm will replace the affected product. It also requested that users return a recall notification acknowledging notification of recall. Users were instructed to contact their sales representative to arrange servicing or for additional information at 1-800-842-8688.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 160
- Distribution
- Worldwide Distribution including USA states of IL, PA, NC, TN, SD, CA, MI, WI, MA, and CO; and country of Japan.
- Date initiated
- 2008-02-25
- Date posted
- 2008-05-21
- Date terminated
- 2008-07-02
- Location
- Kalona, IA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.