Z-0985-02

Block Mold Cutter, Model 8532, Version 1.2

Name: Z-0985-02 Block Mold Cutter, Model 8532, Version 1.2
Creator: Multidata Systems Intl Corp
Published: 2002-11-10
License: https://open.fda.gov/license/

Multidata Systems Intl Corp / initiated 2002-11-10 / Terminated / root cause: labeling and UDI

FDA source

Multidata Systems Intl Corp began a recall of Block Mold Cutter, Model 8532, Version 1.2 on 2002-11-10. The reason FDA records is "The units lacked the required labels per the laser performace standard". 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-0985-02
Status: Terminated
Initiated: 2002-11-10
Posted: 2003-09-13
Terminated: 2003-12-12
Recalling firm: Multidata Systems Intl Corp
Product: Block Mold Cutter, Model 8532, Version 1.2.
Reason for recall: The units lacked the required labels per the laser performace standard.
Root cause tag: labeling and UDI
FDA root cause: Other
Quantity in commerce: 10 units
Distribution: Distribution was made to SC, FL, GA, NY, PA, NC, IL, and NJ.
Product codes and lots: Serial numbers 20128306, 23073201, 21118501, 20023201, 21118502, 21033201, 20028306, 23093201, 22083201, and 20093201

K964167Class IIDecision Support System (for Radiation Oncology)Multidata Systems International Corp. / cleared 1997-03-21

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)