Agency classClass IIOur severity:High FDA (Devices)·Z-0899-2013·Announced 2013-03-06

Philips MX 16-Slice CT Scanner Recall Due to Loose Table Screws

Philips Medical Systems is recalling 412 MX 16-Slice CT Scanner Systems because loose screws may cause the patient table top to detach.

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 structural defect in a medical device that could lead to patient injury (falling table), but the source text does not report any actual injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 412 units of the Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system. The recall is due to a defect where the four screws that secure the patient table top to the carrier became loose, which caused the table top to detach.

The affected units were distributed worldwide, including in the United States in the states of Alabama, Arkansas, California, Florida, Georgia, Illinois, Indiana, Kentucky, Michigan, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, Puerto Rico, and Virginia. The recall covers specific serial numbers listed in the official FDA record Z-0899-2013.

Healthcare facilities should contact Philips Medical Systems for instructions on how to address the defect. The source text does not specify if any injuries or illnesses have been reported as a result of this defect.

The recalled product

Product: Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system.
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Imaging Equipment
Hazard: structural-defect
fall-injury
Affected units: 412

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)

System Code #
728131
Serial #: EP16E090001
EP16E090002
EP16E090003
EP16E090004
EP16E090006
EP16E090007
EP16E090008
EP16E090009
EP16E090010
EP16E090011
EP16E090012
EP16E090013
EP16E090015
EP16E100001
EP16E100004
EP16E100006
EP16E100008
EP16E100010

Distribution

Distributed in 18 states:

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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