Biograph Mct-s With Truev (64) And Truev (40), Biograph Mct-s (40) And (20), Biograph Mct Flow-3r, Flow-4r And Flow Edge-4r (2018-05-16)
Recall Summary Siemens Healthineers is recalling several Biograph PET/CT imaging scanner models distributed across Canada due to a software issue that could cause the device to stop functioning during patient scans. The affected models include the mCT-S with TrueV (64 and 40), mCT-S (40 and 20), and mCT Flow series (3R, 4R, and Edge-4R). Hospitals and imaging centers using these devices are affected by this Class I recall.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2018-06-22
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/43f61484-995b-491a-9cf7-040b17ca0be1