Z-1608-2008

MT-APSD-2.4 Type-S Thermoplastic Mask, Medical charged-particle radiation therapy system; Disposable...

Name: Z-1608-2008 MT-APSD-2.4 Type-S Thermoplastic Mask, Medical charged-particle radiation therapy system; Disposable...
Creator: Civco Medical Instruments Inc
Published: 2008-02-25
License: https://open.fda.gov/license/

CIVCO Medical Instruments Co., Inc. / initiated 2008-02-25 / Terminated / root cause: labeling and UDI

FDA source

Civco Medical Instruments Inc began a recall of MT-APSD-2.4 Type-S Thermoplastic Mask, Medical charged-particle radiation therapy system; Disposable non-sterile (43.2cm) standard perforated thermoplastic... on 2008-02-25. The reason FDA records is "Mislabeled: The mask is mislabeled with the incorrect part number but the outer packaging is correct". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1608-2008
Status: Terminated
Initiated: 2008-02-25
Posted: 2008-05-21
Terminated: 2008-07-02
Recalling firm: CIVCO Medical Instruments Co., Inc.
Product: MT-APSD-2.4 Type-S Thermoplastic Mask, Medical charged-particle radiation therapy system; Disposable non-sterile (43.2cm) standard perforated thermoplastic head, neck and shoulder mask (2.4mm), 1 device per package; CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Mislabeled: The mask is mislabeled with the incorrect part number but the outer packaging is correct.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: 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.
Quantity in commerce: 160
Distribution: Worldwide Distribution including USA states of IL, PA, NC, TN, SD, CA, MI, WI, MA, and CO; and country of Japan.
Product codes and lots: Lot Number: 34415.

Product code IYE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)