Recall Z-1647-2015— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-1647-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-16

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2015-03-16, terminated 2017-02-22. It names one FDA 510(k) clearance: K010817. Product: MX8000 Dualv. EXP, 728130. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.. Reason: The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2015-03-16
Terminated: 2017-02-22
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K010817 — MX8000 V5.0 CT SYSTEMPhilips Medical Systems (Cleveland), Inc.·cleared 2001-06-15

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

MX8000 Dualv. EXP, 728130. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Reason for recall

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

Data sourced from openFDA. This site is unofficial and independent of the FDA.