Philips DigitalDiagnost 4 radiographic systems risk of ceiling mounting failure
Philips DigitalDiagnost 4 Flex/Value radiographic systems may fail when ceiling-mounted and fall, posing injury risk. Recall affects 92 units distributed nationwide.
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 FDA Class II recall involves potential equipment failure and fall hazard that could result in injury, but no injuries have been reported. It qualifies as a risk-of-harm product without reported injury, placing it at severity level 3 per the rubric.
Plain-English summary
Philips North America LLC is recalling DigitalDiagnost 4 Flex/Value radiographic imaging systems due to a potential structural failure in ceiling-mounted units.
The affected devices may fail when suspended from the ceiling and fall, creating a risk of injury to healthcare personnel or patients in the vicinity. This recall affects 92 units that have been distributed nationwide across healthcare facilities.
Facilities using the affected serial numbers should immediately discontinue use and contact Philips North America LLC or the FDA for instructions on safe handling, repair, or replacement. Model numbers 712028, 712227, and 712032 are involved.
The recalled product
- Product
- DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.
- Manufacturer
- Philips North America Llc
- Affected units
- 92
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 (20)
- Model No. 712028
- 712227
- & 712032
- UDI: (01)00884838074514(21)SN18000410
- (01)00884838074514(21)SN18000253
- (01)00884838074514(21)SN18000339
- (01)00884838074514(21)SN18000332
- (01)00884838074514(21)SN18000448
- (01)00884838074514(21)SN18000306
- (01)00884838074514(21)SN18000397
- (01)00884838074514(21)SN18000366
- (01)00884838074514(21)SN18000391
- (01)00884838074514(21)SN18000431
- (01)00884838074514(21)SN19000191
- (01)00884838074514(21)SN19000119
- (01)00884838074514(21)SN19000217
- (01)00884838074514(21)SN19000109
- (01)00884838074514(21)SN19000260
- (01)00884838074514(21)SN20000159
- (01)00884838074514(21)SN19000328
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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