Philips DigitalDiagnost 2.x Upgrades Recalled Due to Footplate Safety Hazard
Philips is recalling DigitalDiagnost 2.x Upgrades because a defective hook allows the footplate to fall or swing, posing a risk of injury to 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a mechanical defect that can cause injury to patients or operators, meeting the criteria for a Severe rating.
Plain-English summary
Philips Medical Systems Gmbh, DMC is recalling DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081. The recall involves specific serial numbers: 428633/SN09000234, 430908/SN09000165, and 487800/SN11000531. These units were distributed nationwide in the United States and internationally to 66 countries.
The recall is being issued 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 injure an operator or patient. The U.S. Food and Drug Administration has classified this as a Class II recall.
Healthcare facilities and users should stop using the affected units immediately. Affected parties should contact Philips Medical Systems Gmbh, DMC for instructions on how to resolve the issue.
The recalled product
- Product
- DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081
- Manufacturer
- Philips Medical Systems Gmbh, DMC
- Category
- Medical Device — Patient Support
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 Numbers: 428633/SN09000234 430908/SN09000165 487800/SN11000531
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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