The Recall Desk
HighFDA (Devices)·Z-1759-2015·Announced 2015-06-17

Philips Medical Systems Recalls MX 16 Slice UPS Accessory Devices

Philips Medical Systems is recalling 125 MX 16 Slice UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.

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, fitting the High severity criteria.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 125 units of MX 16 Slice Uninterruptible Power Supply (UPS) accessory devices. These devices are used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems.

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

Healthcare facilities and consumers should identify affected units by checking the model number 728131 and the specific serial numbers listed in the recall documentation. The firm has been notified of the potential hazards associated with these devices.

The recalled product

Product
MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
125

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 #: 728131
  • Serial #s: EP16E130006
  • EP16E130007
  • EP16E130009
  • EP16E130010
  • EP16E130012
  • EP16E130013
  • EP16E130014
  • EP16E130015
  • EP16E130016
  • EP16E130017
  • EP16E130020
  • EP16E130021
  • EP16E130022
  • EP16E130023
  • EP16E130025
  • EP16E130026
  • EP16E130027
  • EP16E130029
  • EP16E130030

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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