Siemens Mammomat Inspiration Mammography Systems Recalled for Potential Malfunction
Siemens is recalling three Mammomat Inspiration mammography systems due to a potential malfunction that could cause patient bruising during specific imaging procedures.
What this means for you
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 involves a risk-of-harm product where injury (bruising) has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling three units of the Mammomat Inspiration full-field digital mammography system. The recall is due to an unintended behavior where a malfunction may occur during Stereo or Tomo acquisitions if the tomo clutch was incorrectly adjusted.
Although the possibility is rare, the system could move while a patient's breast is compressed, resulting in a possible bruise. The affected units are distributed in North Dakota, Ohio, and South Carolina. The specific model number is 10140000, and the serial numbers are 3118, 3243, and 3309.
Siemens has released Update Instructions XP031/12/S to address this issue. Healthcare facilities should contact Siemens to obtain the update instructions and ensure the systems are properly adjusted to prevent potential patient injury.
The recalled product
- Product
- Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
- 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 (3)
- Model number 10140000
- serial numbers 3118
- 3243 and 3309
Distribution
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