The Recall Desk
HighFDA (Devices)·Z-1760-2015·Announced 2015-06-17

Philips MX 16 Slice Phase II CT Systems Recalled for UPS Battery Hazards

Philips is recalling 11 MX 16 Slice Phase II CT systems because their UPS accessory devices may leak battery acid, overheat, or emit fumes.

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 risk-of-harm product (battery acid leakage, overheating, fumes) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 11 units of the MX 16 Slice Phase II Computed Tomography X-ray systems and Diagnostic Imaging systems. The recall involves specific Uninterruptible Power Supply (UPS) accessory devices used in conjunction with these imaging systems.

The recall was initiated because the UPS accessory devices may fail, resulting in battery acid leakage, overheating, and/or the emission of fumes. The affected units were distributed worldwide, including the United States (nationwide, DC, and Puerto Rico) and numerous international locations.

Healthcare facilities should contact Philips Medical Systems (Cleveland) Inc for instructions on how to address the affected equipment. The specific serial numbers for the affected units are EP16ER100003, EP16ER100004, EP16ER100005, EP16ER100007, EP16ER100008, EP16ER110003, EP16ER110005, EP16ER110006, EP16ER110007, EP16ER110008, and EP16ER110009.

The recalled product

Product
MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
11

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 (11)

  • Model #: 728132
  • Serial #s: EP16ER100003
  • EP16ER100004
  • EP16ER100005
  • EP16ER100007
  • EP16ER100008
  • EP16ER110003
  • EP16ER110005
  • EP16ER110006
  • EP16ER110007
  • EP16ER110008 & EP16ER110009.

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 35 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 35 products in this recall →

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