Philips DigitalDiagnost C90 delivered without required wall stand seismic kit
A DigitalDiagnost C90 radiography system is being recalled because it was delivered without the seismic kit required for the Wall Stand VS2. One unit is affected.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall where a required accessory kit was omitted from delivery, with no clinical consequence described in the source, which fits the Moderate band.
Plain-English summary
The DigitalDiagnost C90 Flex/Value/Chest/ER, model number 712035, UDI (01)00884838090705(21)24861049, lot code 24861049, is being recalled. The action covers one unit.
The stated reason is that the system was delivered without the required seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events. The FDA classified the action as Class II. The source does not describe any defect in the system itself.
Distribution was within the United States, to California. The system is installed in a healthcare facility rather than sold to consumers.
The facility should identify the affected unit using the model number, UDI and lot code above and follow the instructions issued by Philips.
The recalled product
- Product
- DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
- Manufacturer
- Philips North America Llc
- Affected units
- 1
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)
- Model Number: 712035. UDI: (01)00884838090705(21)24861049. Lot Code: 24861049.
Distribution
Distributed in 1 state:
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