Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 4414

FDA device recall Z-0786-2013 · posted 2013-02-26 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents the customers from doing the Daily Image Quality Checks as defined in the current Instructions for Use (IfU).

Action taken

Philips sent a Urgent Medical Device Recall Notice letter dated September 19, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken. This issue does not effect the performance of the Scanner. The Customer Information is intended to inform you about: 1. What the problem is and under what circumstances it can occur. 2. The action you as a customer can take to minimize the effect of this problem. 3 The action planned by Philips to correct this problem. If you need any further information or support concerning this issue please contact your local Philips Representative. In the US and Canada please contact the Philip's Healthcare customer care solutions at 1-800-722-9377, and follow the recorded menu options to reach a Customer Solutions Engineer. In all other countries please contact your local Philips Healthcare office.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

JAK

Quantity affected

1,474 Units

Distribution

Worldwide Distribution - USA ( nationwide) including the states of AK, AL, AR, AZ, CA, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, O

Date initiated

2012-09-18

Date posted

2013-02-26

Date terminated

2015-09-02

Location

Cleveland, OH