Philips DigitalDiagnost 2.x Upgrades Recalled Due to Footplate Injury Risk
Philips is recalling two DigitalDiagnost 2.x Upgrades because a defective hook allows the footplate to fall or swing, posing a risk of injury to operators or patients.
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 is classified as FDA Class II and involves a risk of physical injury to patients or operators, but the source text does not report any actual injuries or hospitalizations, placing it in the 'High' severity category.
Plain-English summary
Philips Medical Systems Gmbh, DMC is recalling two units of DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082. The recall affects specific serial numbers: 496224/SN12000042 and 431530/SN09000159. These units were distributed in the United States and internationally to 66 countries.
The recall was initiated because the hook on the device does not securely hold the footplate in the vertical position. As a result, the footplate can fall or swing down, which may cause injury to an operator or patient.
Healthcare facilities and users should stop using the affected units immediately. Users should contact Philips Medical Systems for instructions on how to resolve the issue or obtain a replacement.
The recalled product
- Product
- DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082
- Manufacturer
- Philips Medical Systems Gmbh, DMC
- Affected units
- 2
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)
- Serial Numbers: 496224/SN12000042
- 431530/SN09000159
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 28 recalled by Philips Medical Systems Gmbh, DMC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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