Recall Z-0899-2013— Philips Medical Systems (Cleveland) Inc
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2012-12-19, terminated 2013-12-03. It names one FDA 510(k) clearance: K083498. Product: Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system.. Reason: The four screws that secure the patient table top to the carrier became loose, which caused the table top to detach..
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-12-19
- Terminated
- 2013-12-03
- Firm location
- Cleveland, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system.
Reason for recall
The four screws that secure the patient table top to the carrier became loose, which caused the table top to detach.
Data sourced from openFDA. This site is unofficial and independent of the FDA.