The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0704-2018·Announced 2018-03-07

Philips ProGrade R1 Digital X-Ray Detector Recall for Image Transfer Failures

Philips is recalling 157 ProGrade R1 digital x-ray detectors because weak WiFi connections can cause image transfer failures, requiring patients to be re-exposed to radiation.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a functional defect leading to image loss and potential re-exposure to radiation, but no injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Philips Electronics North America Corporation is recalling 157 units of the ProGrade R1 solid state X-ray imager (flat panel/digital imager). The recall covers devices distributed nationwide in the United States and internationally to Canada. The ProGrade R1 is intended to acquire, process, store, display, and export digital radiographic images for routine examinations, excluding mammography.

The recall is due to a defect where a weak WiFi connection between the SkyPlate detector and the HP transfer point can cause an image to fail to transfer. When this occurs, the image remains in the detector's memory but cannot be transferred wirelessly or via the backup cable. To continue operations, the operator must reset the detector by removing its batteries, which results in the loss of the acquired image and necessitates a re-take of the x-ray.

Healthcare facilities using these devices should contact Philips for instructions on how to resolve the issue. Patients who had x-rays taken with these devices may have been re-exposed to radiation if an image transfer failure occurred and a re-take was required.

The recalled product

Product
digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips ProGrade is intended to acquire, process, store, display, and export digital radiographic images. The Philips ProGrade is suitable for…
Manufacturer
Philips Electronics North America Corporation
Category
Medical Device — Imaging Equipment
Hazard
Affected units
157

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 (2)

  • ProGrade R1
  • solid state X ray imager

Distribution

Distributed nationwide across the United States.

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