Hologic M-IV Mammography System Recalled for Defective Emergency Off Switch
Hologic is recalling three M-IV Mammography Systems because a defective relay switch may prevent the emergency off switch from working, posing a risk of patient injury.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of patient injury due to a safety mechanism failure, but no specific injuries or hospitalizations are reported in the source text.
Plain-English summary
Hologic, Inc. is recalling three units of the M-IV Mammography System, Model M4--00001. The recall is due to a defective relay switch that may prevent the system from turning off if the emergency off switch is used. This malfunction could result in patient injury.
The affected units were distributed in Puerto Rico, California, New York, Texas, and the Republic of Korea. The specific serial numbers for the recalled units are 1800314 7263, 180031472, and 18002023051PR.
Healthcare facilities should contact Hologic, Inc. to arrange for the repair or replacement of the defective relay switch. Patients who have undergone mammography on these specific units should consult their healthcare provider if they have concerns regarding their imaging or safety.
The recalled product
- Product
- Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.
- Manufacturer
- Hologic, Inc.
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Serial Numbers: 1800314 7263
- 180031472
- 18002023051PR
Distribution
Part of a larger recall action
This product is one of 2 recalled by Hologic, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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