Recall Z-1722-2014— Philips Medical Systems (Cleveland) Inc
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2014-04-01, terminated 2018-06-26. It names 5 FDA 510(k) clearances: K060937, K033357, K033326 and 2 more. Product: Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners). Reason: A customer reported that the table top had become free floating. A Field Service Engineer (FSE) confirmed that the service latch had become disengaged..
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-01
- Terminated
- 2018-06-26
- Firm location
- Cleveland, OH, United States
510(k) clearances named in this recall
5 on FDA's record- K060937 — BRILLIANCE VOLUME
- K033357 — ACQSIM-MULTISLICE-CT, MODEL 453567042271
- K033326 — PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
- K012009 — MX8000 IDT CT SYSTEM
- K010817 — MX8000 V5.0 CT SYSTEM
K-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 Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners)
Reason for recall
A customer reported that the table top had become free floating. A Field Service Engineer (FSE) confirmed that the service latch had become disengaged.
Data sourced from openFDA. This site is unofficial and independent of the FDA.