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.
What this means for you
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
- 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
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.
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