Siemens Mammomat Inspiration Mammography Systems Recalled for Safety Switch Defect
Siemens is recalling three Mammomat Inspiration mammography systems because a safety switch defect may allow the needle positioning device to move during a biopsy.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device that could lead to significant injury if the needle moves during a biopsy.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling three units of the Mammomat Inspiration mammography system. The recall is due to a defect in the stereo biopsy devices where the safety switch may fail to function correctly. Specifically, the pin in the safety switch may not apply enough pressure to the safety circuit to prohibit movement, allowing the needle positioning device to move even when the safety switch is set to the side.
This defect poses a risk if the needle positioning device moves while the needle is already inserted into the patient. The affected systems are distributed in New York, Virginia, and Massachusetts. The specific units are identified by material number 10140000 and serial numbers 5018, 3849, and 5042.
Healthcare facilities using these systems should contact Siemens Medical Solutions USA, Inc. to arrange for the necessary repairs or replacements. Patients who have undergone procedures on these specific units should consult their healthcare provider if they have concerns about the procedure.
The recalled product
- Product
- Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy…
- Manufacturer
- Siemens Medical Solutions USA, 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 (2)
- material #10140000
- with serial numbers: 5018 3849 5042
Distribution
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