Z-0149-04

Lorad MIV Platinum Mammograpgy System

Name: Z-0149-04 Lorad MIV Platinum Mammograpgy System
Creator: Lorad, A Division of Hologic
Published: 2004-01-14
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2004-01-14 / Terminated

FDA source

Lorad, A Division of Hologic began a recall of Lorad MIV Platinum Mammograpgy System on 2004-01-14. The reason FDA records is "System failed to meet the mA's accuracy specfications at low mA's values". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0149-04
Status: Terminated
Initiated: 2004-01-14
Posted: 2004-08-11
Terminated: 2004-09-15
Recalling firm: Hologic, Inc.
Product: Lorad MIV Platinum Mammograpgy System
Product code: IZH System, X-Ray, Mammographic
Reason for recall: System failed to meet the mA's accuracy specfications at low mA's values
FDA root cause: Other
Action: Lorad notified customers/dealers by letter dated January 14, 2004. Sites were advised of the corrected Accuracy labeling.
Distribution: Nationwide
Product codes and lots: S/N''s :18005960001 to 18010034196

Product code IZH

K011987Class IIModified M-IV Mammography SystemLorad, A Hologic Co. / cleared 2001-07-11

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)