Agency classClass IIOur severity:Severe FDA (Devices)·Z-2681-2016·Announced 2016-09-07

Philips PCR Compano Basic Reader Recalled for Power Supply Fire Hazard

Philips is recalling 388 PCR Compano Basic Reader units because a defective power supply component can burn and release smoke.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 a fire hazard (burning power supply and smoke), which aligns with the 'Severe' criteria for significant injury/property-damage reports or high-risk defects.

Plain-English summary

Philips Electronics North America Corporation is recalling 388 units of the PCR Compano Basic Reader, a radiological image processing system used for Computed Radiography. The affected models are 732027, 732028, and 732040, which use 100-127V as mains voltage. The recall is classified as Class II by the U.S. Food and Drug Administration.

The recall is due to a defect in the power supply component that can cause the power supply to burn and allow some smoke to leave the housing. This defect poses a potential fire and smoke hazard. The affected units were distributed worldwide, including in the United States, Canada, Brazil, Germany, Iraq, Japan, Korea, Kuwait, Libya, Mexico, Portugal, and Qatar.

Consumers and healthcare facilities should identify affected units by checking the model numbers and serial numbers listed in the official recall notice. Users should contact Philips Electronics North America Corporation for instructions on how to resolve the issue, which may involve repair or replacement of the defective component.

The recalled product

Product: PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography).
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — Radiological Image Processing
Hazard: fire
smoke
Affected units: 388

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 (1)

and SN36125302.

Distribution

Distributed in 41 states:

Same manufacturer · Philips Electronics North America Corporation

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Same hazard · fire