Interventional fluoroscopic x-ray system may incorrectly report radiation dose
Siemens interventional x-ray systems may fail to correctly report radiation dose in very rare cases due to sensor-software communication failures. When this occurs, the system incorrectly reports high-dose readings.
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: FDA Class II recall of medical imaging equipment presenting a theoretical risk-of-harm: sensor-software communication failure may cause incorrect dose reporting. No injuries or illnesses have been reported, and the malfunction occurs in very rare situations.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling certain interventional fluoroscopic x-ray systems worldwide. These systems are used for image-guided interventional procedures in medical facilities.
In very rare situations, communication between the sensor that measures applied dose and the corresponding software fails. When this occurs, the system may incorrectly report an application of a high dose. This failure means the facility cannot reliably determine the actual radiation dose delivered during a procedure.
The systems are distributed worldwide. The FDA has assigned this recall Class II status. Facilities operating these systems should contact Siemens Medical Solutions for information about corrective measures or guidance regarding continued use.
The recalled product
- Product
- interventional fluoroscopic x-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- dose-miscalibration
- sensor-failure
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)
- 4056869295923
Distribution
Distribution scope not specified by the agency.
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