Z-0124-2010

CIVCO MTAPSID2932 Type-S Thermoplastic, Disposable nonsterile (48.3 cm) IMRT Style 29 thermoplastic (3.2 mm)...

Name: Z-0124-2010 CIVCO MTAPSID2932 Type-S Thermoplastic, Disposable nonsterile (48.3 cm) IMRT Style 29 thermoplastic (3.2 mm)...
Creator: Med Tec Inc
Published: 2009-08-31
License: https://open.fda.gov/license/

Medtec LLC / initiated 2009-08-31 / Terminated / root cause: manufacturing process

FDA source

Med Tec Inc began a recall of CIVCO MTAPSID2932 Type-S Thermoplastic, Disposable nonsterile (48.3 cm) IMRT Style 29 thermoplastic (3.2 mm), Ref. MTAPSID2932, disposable frame mask, 5 per... on 2009-08-31. The reason FDA records is "Some of the packages contain the incorrect mask style". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0124-2010
Status: Terminated
Initiated: 2009-08-31
Posted: 2009-11-06
Terminated: 2012-03-07
Recalling firm: Medtec LLC
Product: CIVCO MTAPSID2932 Type-S Thermoplastic, Disposable nonsterile (48.3 cm) IMRT Style 29 thermoplastic (3.2 mm), Ref. MTAPSID2932, disposable frame mask, 5 per box. The firm name on the label is CIVCO, Orange City, IA. Intended to be used for patient fixation.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Some of the packages contain the incorrect mask style.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 12 boxes
Distribution: Worldwide Distribution -- USA, including states of FL, TX, and OH and country of Australia.
Product codes and lots: Lot M121560

Product code IYE

K933227Class IIUni-Frame Head Immobilization SystemMedtec, Inc. / cleared 1994-07-18

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)