The Recall Desk
HighFDA (Devices)·Z-1789-2015·Announced 2015-06-17

Philips Recalls GEMINI TF Big Bore UPS Accessory Devices for Leakage Risk

Philips Medical Systems is recalling 39 GEMINI TF Big Bore 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 (medical device accessory) where injury has not yet been reported, and the agency classification is Class II, which aligns with the 'High' severity criteria for unreported injury risks.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 39 GEMINI TF Big Bore Uninterruptible Power Supply (UPS) accessory devices. These devices are used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. The recall covers units distributed worldwide, including the United States, DC, Puerto Rico, and numerous international locations.

The recall was initiated because the firm was notified that the failure of these UPS accessory devices may result in battery acid leakage, overheating, and/or the emission of fumes. The affected units are identified by Model # 882476 and specific serial numbers ranging from 9015 to 9233.

Healthcare facilities and users of these diagnostic imaging systems should verify if they possess the affected serial numbers. The source text does not specify a consumer action plan, but users should contact the recalling firm for instructions on how to address the potential hazards associated with the UPS devices.

The recalled product

Product
GEMINI TF Big Bore (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 Accessory
Hazard
Affected units
39

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 #: 882476
  • Serial #s: 9015
  • 9016
  • 9017
  • 9018
  • 9019
  • 9020
  • 9021
  • 9022
  • 9023
  • 9201
  • 9202
  • 9203
  • 9204
  • 9205
  • 9206
  • 9207
  • 9208
  • 9209
  • 9210

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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