Recall Z-1695-2015— Philips Medical Systems (Cleveland) Inc
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2015-04-13, terminated 2015-10-01. It names one FDA 510(k) clearance: K060937. Product: Brilliance iCT Computed Tomography X-ray system. Reason: A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners..
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-13
- Terminated
- 2015-10-01
- 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
Brilliance iCT Computed Tomography X-ray system
Reason for recall
A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.
Data sourced from openFDA. This site is unofficial and independent of the FDA.