The Recall Desk
HighFDA (Devices)·Z-2465-2012·Announced 2012-10-03

Philips Digital Diagnost Mobile Detector Holder Recall for Insecure Fit

Philips is recalling 93 Mobile Detector Holders because the Wireless Portable Detector may not be fixed securely and could fall down.

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 medical device where a component may fall, creating a risk of injury or property damage, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Philips Healthcare Inc. is recalling 93 units of the Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) systems. The affected systems are used for making X-ray exposures for diagnostics and carry system codes 712020, 712022, and 712025.

The recall was initiated because the Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and may fall down. The affected units were distributed worldwide, including in the United States (nationwide), Australia, Austria, Canada, Chile, Finland, France, Germany, Hungary, Italy, Japan, Latvia, Netherlands, New Zealand, Oman, South Korea, Switzerland, and the United Kingdom.

Healthcare facilities and users should check their serial numbers against the list provided in the official recall notice to determine if their equipment is affected. Specific instructions for remediation or replacement should be obtained directly from Philips Healthcare Inc.

The recalled product

Product
Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 712022, 712025 This system is used for making X-ray exposures for diagnostics.
Affected units
93

Distribution

Distributed nationwide across the United States.