The Recall Desk
HighFDA (Devices)·Z-1782-2015·Announced 2015-06-17

Philips Gemini LXL 16 Slice CT Systems Recalled for UPS Defects

Philips is recalling 10 Gemini LXL 16 Slice CT systems worldwide due to UPS accessory defects that may cause battery acid leakage, overheating, or 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, fitting the 'High' severity criteria for theoretical hazards without confirmed harm.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 10 units of the Gemini LXL 16 Slice Computed Tomography X-ray systems and Diagnostic Imaging systems. The recall involves Uninterruptible Power Supply (UPS) accessory devices associated with these systems. The affected units are identified by Model # 882412 and specific serial numbers ranging from 14701 to 14711.

The recall was initiated because the UPS accessory devices may fail, resulting in battery acid leakage, overheating, and/or the emission of fumes. These hazards are associated with the power supply components used in conjunction with the imaging systems.

The affected products were distributed worldwide, including the United States (nationwide, DC, and Puerto Rico) and numerous international locations. The source text does not specify instructions for consumers or healthcare facilities regarding the immediate handling of these devices, nor does it report any specific injuries or illnesses associated with the defect.

The recalled product

Product
Gemini LXL 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
10

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 (10)

  • Model #: 882412
  • Serial #s: 14701
  • 14702
  • 14704
  • 14705
  • 14706
  • 14707
  • 14708
  • 14709
  • 14710 & 14711.

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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