The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1761-2015·Announced 2015-06-17

Philips Recalls CT Scanner UPS Accessories Due to Battery Acid Leakage Risk

Philips Medical Systems is recalling 788 Uninterruptible Power Supply (UPS) accessories for CT scanners due to risks of battery acid leakage, overheating, and fume emission.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 battery acid leakage and fume emission, which poses a potential for chemical burns or respiratory irritation. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 788 Uninterruptible Power Supply (UPS) accessory devices used in conjunction with Brilliance CT 64 channel with Essence Computed Tomography X-ray systems and Diagnostic Imaging systems. The recall was initiated after the firm was notified that the failure of these UPS accessory devices may result in battery acid leakage, overheating, and/or emission of fumes.

The affected units were distributed worldwide, including the United States (nationwide, including DC & Puerto Rico) and numerous international locations. The specific model number is 728231, and the recall covers a specific range of serial numbers listed in the official agency documentation.

Consumers and healthcare facilities should check their equipment for the affected model and serial numbers. If the equipment matches the description, they should contact Philips Medical Systems for further instructions on how to address the potential safety hazard.

The recalled product

Product
Brilliance CT 64 channel with Essence, Technology (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 Systems
Hazard
Affected units
788

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 #: 728231
  • Serial #s: 7521
  • 7546
  • 9038
  • 9043
  • 9044
  • 9047
  • 9050
  • 9072
  • 9106
  • 9120
  • 9152
  • 9168
  • 9234
  • 9250
  • 9516
  • 9526
  • 9535
  • 9551
  • 9552

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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