Recall Z-2386-2012— Philips Medical Systems (Cleveland) Inc
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2012-08-24, terminated 2013-08-28. It names 2 FDA 510(k) clearances: K091195, K083498. Product: MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.. Reason: On August 24, 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry..
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-24
- Terminated
- 2013-08-28
- Firm location
- Cleveland, OH, United States
510(k) clearances named in this recall
2 on FDA's record- K091195 — PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511
- K083498 — PHILIPS MODEL MX 16 SLICE 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
MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.
Reason for recall
On August 24, 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
Data sourced from openFDA. This site is unofficial and independent of the FDA.