The Recall Desk
SevereFDA (Devices)·Z-1783-2015·Announced 2015-06-17

Philips TruFlight Select PET/CT Uninterruptible Power Supply Recall

Philips is recalling 31 TruFlight Select PET/CT systems because the Uninterruptible Power Supply (UPS) accessory devices may leak battery acid, overheat, or emit fumes.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device with a potential for battery acid leakage, overheating, and fume emission, which poses a significant risk of injury or property damage, meeting the criteria for a Severe (Score 4) classification.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 31 units of the TruFlight Select PET/CT 16-slice Computed Tomography X-ray and Diagnostic Imaging systems. The recall involves the Uninterruptible Power Supply (UPS) accessory devices used in conjunction with these 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, including DC and Puerto Rico) and numerous international locations.

Healthcare facilities and consumers should contact Philips Medical Systems (Cleveland) Inc for instructions on how to address the defective UPS accessory devices. The specific model number is 882438, and the affected serial numbers range from 17002 to 17038.

The recalled product

Product
TruFlight Select PET/CT 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 — Diagnostic Imaging
Hazard
Affected units
31

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 #: 882438
  • Serial #s: 17002
  • 17003
  • 17004
  • 17006
  • 17007
  • 17008
  • 17009
  • 17011
  • 17012
  • 17013
  • 17014
  • 17015
  • 17017
  • 17018
  • 17019
  • 17021
  • 17022
  • 17023
  • 17024

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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