Philips DigitalDiagnost C90 radiography system ceiling-mount failure risk
Philips is recalling two units of its DigitalDiagnost C90 Release 3.1 radiographic imaging system due to potential failure of ceiling-mounted units, which could fall.
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: This is an FDA Class II recall involving a risk-of-harm product (ceiling-mounted medical imaging system with potential to fall) where no injuries or deaths have been reported. The hazard presents significant injury risk should units fail, but the absence of reported incidents places it in the High category per the rubric.
Plain-English summary
Philips North America LLC is recalling two units of the DigitalDiagnost C90 Release 3.1, a digital radiographic imaging system used to acquire, process, store, display and export radiographic images. The units have serial numbers SN14000197 and SN14000260, Model No. 712026.
The recall is due to a potential for ceiling-suspended units to fail and fall. Ceiling-mounted installation presents a risk of the device falling unexpectedly.
The affected units were distributed nationwide. Healthcare facilities using this equipment should contact Philips North America LLC immediately. Do not use any ceiling-mounted DigitalDiagnost C90 Release 3.1 units that match the recalled serial numbers until the issue has been resolved or the device has been retrofitted or removed.
The recalled product
- Product
- DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.
- Manufacturer
- Philips North America Llc
- 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)
- Model No. 712026
- Serial No. SN14000197 & SN14000260.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Philips North America Llc 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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