Philips Digital Diagnost Patient Carriage Footplate Recall
Philips is recalling Digital Diagnost patient carriages because the footplate hook may fail, causing the footplate to fall on patients or operators.
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-harm product where the footplate may fall on a patient or operator, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Healthcare Inc. is recalling the Philips Digital Diagnost with patient carriage, Model 712050, with serial numbers ranging from 00 000 00 to 09 000 543. The recall involves 536 units of this stationary radiographic system.
The recall is being issued because the hook does not securely hold the footplate in the vertical position. This defect may cause the footplate to disengage and fall on a patient or operator.
The affected units were distributed worldwide, including in the United States and numerous other countries. Users of these devices should contact Philips Healthcare Inc. for instructions on how to resolve the issue.
The recalled product
- Product
- Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09 000 543. Product Usage: Stationary radiographic System
- Manufacturer
- Philips Healthcare Inc.
- Affected units
- 536
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)
- Serial number range (patient carriage) from: 00 000 00 to 09 000 543.
Distribution
Distributed nationwide across the United States.
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