Philips Digital Diagnost Radiographic System Recall Due to Footboard Defect
Philips is recalling 985 Digital Diagnost stationary radiographic systems because the footboard may not be securely held if the fix clamp is not correctly adjusted.
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 medical device with a mechanical defect that could lead to patient injury if the footboard is not securely held. No injuries or illnesses have been reported, but the risk of harm is present, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems, Inc. is recalling 985 units of the Digital Diagnost stationary radiographic system. The affected models include 712020, 712022, 712025, 712026, 712050, 712052, 712054, 712055, 712057, 712060, 712062, 712080, 712081, 712082, and 712085. These devices were distributed nationwide in the United States and worldwide, including Canada and Mexico, from November 2006 through March 2014.
The recall is due to a defect in the patient support footboard. The footboard can be fixed in the upper position, but if the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held. This could potentially allow the footboard to move or shift during use.
Healthcare facilities and users of these devices should contact Philips Medical Systems, Inc. for instructions on how to resolve the issue. The source text does not specify a particular action such as repair or replacement, but users should follow the manufacturer's guidance to ensure the device is safe to use.
The recalled product
- Product
- Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 985
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)
- Units distributed from November 2006 through March 2014.
Distribution
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