Siemens Interventional Fluoroscopic X-Ray System Dose Reporting Failure
Siemens interventional fluoroscopic x-ray systems may fail to accurately report applied radiation dose in rare situations due to sensor-software communication failures, potentially providing inaccurate dose information to clinical staff.
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: This is a Class II medical device recall involving potential dosimetry reporting failure that could provide inaccurate radiation dose information to clinical staff. While described as occurring in very rare situations with no reported incidents mentioned in the source, the potential for patient harm through incorrect dose information in a medical device justifies a High severity rating.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling interventional fluoroscopic x-ray systems distributed worldwide. The systems are subject to a rare communication failure between the dose measurement sensor and system software.
In very rare situations, communication between the sensor measuring dose applied to an area and the corresponding software may fail. When this occurs, the system may incorrectly report an application of a high dose.
Interventional fluoroscopic x-ray systems are used by medical facilities for image-guided surgical and diagnostic procedures. This recall affects systems distributed worldwide.
For additional information regarding this recall and any recommended measures, healthcare facilities should contact Siemens Medical Solutions USA, Inc.
The recalled product
- Product
- interventional fluoroscopic x-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- dosimetry-failure
- software-malfunction
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 (1)
- 4056869149325
Distribution
Distribution scope not specified by the agency.
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