Recall Z-2112-2016— Philips Medical Systems (Cleveland) Inc
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2016-06-21, terminated 2018-07-02. It names one FDA 510(k) clearance: K060937. Product: Brilliance iCT model #728306; Intended to produce cross- sectional images of the body.. Reason: Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack..
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-21
- Terminated
- 2018-07-02
- 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 model #728306; Intended to produce cross- sectional images of the body.
Reason for recall
Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack.
Data sourced from openFDA. This site is unofficial and independent of the FDA.