Reported Jun 11, 2014 · Terminated
Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening…
Hologic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc. · 36 Apple Ridge Rd # 37 · Danbury, CT · 06810-7301
Is this the product you have?
- Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.
- Lot codes and dates
- Serial Numbers
1800314 726318003147218002023051PR
- Serial Numbers
- Amount recalled
- 3 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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