Recall Z-0376-2017— Philips Electronics North America Corporation
Class II · Terminated
Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2016-03-15, terminated 2020-09-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Philips Healthcare System X-ray Tomography Computed :. Reason: It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure..
- Recalling firm
- Philips Electronics North America Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-15
- Terminated
- 2020-09-09
- Firm location
- Andover, MA, United States
Product description
Philips Healthcare System X-ray Tomography Computed :
Reason for recall
It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.
Data sourced from openFDA. This site is unofficial and independent of the FDA.