The Recall Desk
HighFDA (Devices)·Z-1765-2015·Announced 2015-06-17

Philips CT Scanner UPS Accessory Recall for Battery Acid Leakage

Philips Medical Systems is recalling 847 UPS accessory devices for CT scanners 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, which aligns with the 'High' severity criteria for medical devices.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 847 Uninterruptible Power Supply (UPS) accessory devices used with Brilliance CT 16 Slice Air Computed Tomography X-ray systems and Diagnostic Imaging systems. The recall was initiated after the firm was notified that the failure of these UPS devices may result in battery acid leakage, overheating, and/or the emission of fumes.

The affected devices are distributed worldwide, including the United States (nationwide, DC, and Puerto Rico) and numerous international locations. The specific model number is 728246, and the recall covers a specific list of serial numbers ranging from 3007 to 260086.

Consumers and healthcare facilities should check their equipment against the provided serial number list. If a device is affected, the firm should be contacted to arrange for the necessary corrective action to address the potential safety hazards.

The recalled product

Product
Brilliance CT 16 Slice Air (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
847

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 #: 728246
  • Serial #s: 3007
  • 3011
  • 3014
  • 3047
  • 3050
  • 3095
  • 3117
  • 3123
  • 3162
  • 3164
  • 3170
  • 3197
  • 3247
  • 3331
  • 3407
  • 3433
  • 3458
  • 3497
  • 3578

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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