Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0190-2015·Announced 2014-11-19

Philips MX 16-slice CT Scanner Recalled for Incorrect Image Orientation

Philips Medical Systems is recalling 708 MX 16-slice CT Scanner Systems because scan images may display left and right sides reversed, potentially leading to misinterpretation of patient position.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect image orientation which could lead to diagnostic errors, but the source text does not report any specific injuries, hospitalizations, or deaths, fitting the criteria for a moderate severity recall.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 708 units of the MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11. The recall is due to a software defect where the orientation of images is displayed incorrectly. Specifically, when the operator selects "gantry on the right side" from the operation console and the patient position is set to HFDL, HFDR, FFDL, or FFDR, the patient position picture and text are inconsistent. In these instances, the "L" and "R" markers on the scan images are reversed and do not match the patient's actual position.

The affected devices are distributed domestically in 21 U.S. states and territories, as well as in numerous foreign countries including Albania, Algeria, Argentina, Australia, and others. The recall covers specific model numbers 728131 and 728132 with a long list of associated serial numbers.

Healthcare facilities should contact Philips Medical Systems to arrange for a software update or repair to correct the image orientation issue. This defect could lead to misinterpretation of scan images if the left and right sides are not correctly identified relative to the patient's anatomy.

The recalled product

Product: MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY…
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Imaging Equipment
Hazard: mis-labeling
diagnostic-error
Affected units: 708

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Model Number: 728131
Serial Number(s): EP16E090001
EP16E090002
EP16E090003
EP16E090004
EP16E090006
EP16E090007
EP16E090008
EP16E090009
EP16E090010
EP16E090011
EP16E090012
EP16E090013
EP16E090015
EP16E100001
EP16E100004
EP16E100005
EP16E100006
EP16E100007
EP16E100008

Distribution

Distributed in 20 states:

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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