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Terminated

Block Mold Cutter, Model 8532, Version 1.2.

FDA Recall Z-0985-02 · Posted 2003-09-13

Recalling FirmMultidata Systems Intl Corp
Recall StatusTerminated
Date Initiated2002-11-10
Date Terminated2003-12-12
Product Quantity10 units

Reason for Recall

The units lacked the required labels per the laser performace standard.

Root Cause

Other

Distribution Pattern

Distribution was made to SC, FL, GA, NY, PA, NC, IL, and NJ.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964167DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY)Multidata Systems International Corp. · 1997-03-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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