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Terminated

Lorad MIV Platinum Mammograpgy System

FDA Recall Z-0149-04 · Posted 2004-08-11

Recalling FirmLorad, A Division of Hologic
Recall StatusTerminated
Product CodeIZH
Date Initiated2004-01-14
Date Terminated2004-09-15

Reason for Recall

System failed to meet the mA's accuracy specfications at low mA's values

Firm Action

Lorad notified customers/dealers by letter dated January 14, 2004. Sites were advised of the corrected Accuracy labeling.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011987MODIFIED M-IV MAMMOGRAPHY SYSTEMLorad, A Hologic Co. · 2001-07-11

Official Source

View FDA Recall →

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

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