Computed Tomography X-Ray System MX 8000 IDT 16; Model # 728120; Serial #'s: 2513, 2518, 3147, 3217, 3014, 3050, 3068, 3188, 3091, 3051, 3099, 3126, 3183, 3303, 2539 & 3056. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
FDA Recall Z-0133-2011 · Posted 2010-10-22
Advertisement
Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2010-07-27
Date Terminated2012-09-21
Product Quantity16 units
Reason for Recall
Philips Healthcare has decided to recall the Computed Tomography X-Ray System MX 8000 IDT due to the fact that the software upgrade for the MX 8000 IDT 16 v4.2.1 may not provide the optional collimation of 4x4.5 (18mm). If the customer does not verify the increment and thickness coincide with the newly selected collimation suggested by the conversion report, there is potential for a 6mm gap to ap
Firm Action
Philips Medical Systems (Cleveland), Inc. sent an URGENT - Field Safety Notice dated July 29, 2010 and August 23, 2010 to all customers. The notices identified the product, the problem, and the steps to be taken.
Customers were instructed to locate and correct the error.
Field Service Engineers were to visit each site to update the software
For further information customers were to contact their local Philips Customer Care Center at 1-800-722-9377
Root Cause
Software change control
Distribution Pattern
Product was sold in the following states: CA, DE, IN,OR, MA, NV, TN. Product was also sold in Canada and Australia
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement