Agency classClass IIOur severity:High FDA (Devices)·Z-2347-2016·Announced 2016-08-17

Philips MX 16-slice CT Systems Recalled for Software Defects

Philips is recalling 80 MX 16-slice CT systems due to software bugs that may cause image mix-ups or scan interruptions.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with software defects that could lead to diagnostic errors (image mix-ups) or procedural interruptions, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Philips Medical Systems (Cleveland) Inc. is recalling 80 units of the MX 16-slice SKD whole body computed tomography X-ray system. The recall involves specific serial numbers for Model No. 728132 and Model No. 728135. These systems were distributed to facilities in 18 U.S. states and numerous countries worldwide.

The recall is due to three software issues found in version 1.1.4.21426. First, the image clipboard is not cleared between patients, which may result in previous patient images being pasted onto the current patient's film if the operator does not manually clear it. Second, the Bolus Tracking scan may abort unexpectedly if Auto Voice is enabled, requiring the operator to manually start the subsequent diagnostic scan. Third, the Spiral Auto Start (SAS) option may not display or enable correctly on the first helical scan after system startup.

Healthcare facilities using these systems should contact Philips Medical Systems for instructions on software updates or repairs. Patients who had scans performed on these systems should consult their healthcare providers if they have concerns about image accuracy or scan interruptions.

The recalled product

Product: MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Computed Tomography (CT) Scanner
Hazard: software-defect
diagnostic-error
scan-interruption
Affected units: 80

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 No. 728132
S/N: EP16ER100003
EP16ER100004
EP16ER100005
EP16ER100007
EP16ER100008
EP16ER110003
EP16ER110004
EP16ER110005
EP16ER110006
EP16ER110007
EP16ER110008
EP16ER110009
EP16ER110010
EP16ER110011
EP16ER110012
EP16ER110013
EP16ER110014
EP16ER110015
EP16ER110016

Distribution

Distributed in 18 states:

Part of a larger recall action

This product is one of 2 recalled by Philips Medical Systems (Cleveland) Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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