The Recall Desk
SevereFDA (Devices)·Z-1781-2015·Announced 2015-06-17

Philips Gemini GXL 16 Slice CT Systems Recalled for UPS Battery Hazards

Philips is recalling 15 Gemini GXL 16 Slice CT systems worldwide because their 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 is classified as FDA Class II and involves significant injury risks, including battery acid leakage, overheating, and fume emission, which aligns with the 'Severe' criteria for significant injury reports or high-risk defects.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 15 units of the Gemini GXL 16 Slice Computed Tomography X-ray systems and Diagnostic Imaging systems. The recall involves specific Uninterruptible Power Supply (UPS) accessory devices used with these systems. The affected units are identified by Model # 882410 and specific serial numbers listed in the recall notice.

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 rather than the primary imaging functions of the CT systems.

The affected units were distributed worldwide, including the United States (nationwide, DC, and Puerto Rico) and numerous international locations. Healthcare facilities and users of these specific serial numbers should contact Philips Medical Systems for instructions on how to address the defect.

The recalled product

Product
Gemini GXL 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 — Computed Tomography (CT) Systems
Hazard
Affected units
15

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 (15)

  • Model #: 882410
  • Serial #s: 3025
  • 4003
  • 4026
  • 4067
  • 4076
  • 4087
  • 4097
  • 4102
  • 4123
  • 4134
  • 4201
  • 4202
  • 4205
  • 4206 & 4042003.

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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