DigitalDiagnost 4 Ceiling-Mounted X-Ray Units Recall for Fall Hazard
Philips is recalling 13 DigitalDiagnost 4 Chest/Emergency radiographic imaging units due to a potential for ceiling-mounted units to fail and fall, posing injury risk.
What this means for you
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 a risk-of-harm scenario (ceiling-mounted equipment falling) with no reported injuries or illnesses. The hazard is theoretical—potential rather than actual. Per the rubric, risk-of-harm products without reported injury score 3, and theoretical hazards score at most 3.
Plain-English summary
Philips North America LLC is recalling 13 units of the DigitalDiagnost 4 Chest/Emergency, a digital radiographic imaging system used to acquire, process, store, display and export X-ray images. The recall concerns a potential for ceiling-mounted units to fail mechanically and fall.
The affected units have been distributed nationwide.
Owners of the affected DigitalDiagnost 4 Chest/Emergency units should contact Philips North America LLC immediately with their serial number to determine if their unit is affected and for instructions on remediation or replacement.
The recalled product
- Product
- DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
- Manufacturer
- Philips North America Llc
- Hazard
- equipment-failure
- fall-hazard
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. 712029 & 712033
- UDI: (01)00884838074521(21) SN19000272
- (01)00884838074521(21) SN19000213
- (01)00884838074521(21) 10001077
- (01)00884838074521(21) SN20000097
- (01)00884838074521(21) SN16000074
- (01)00884838074521(21) SN15000238
- (01)00884838074521(21) SN16000075
- (01)00884838074521(21) SN15000367
- (01)00884838074521(21) SN18000428
- (01)00884838074521(21) SN17000318
- (01)00884838074521(21) SN18000309
- (01)00884838074521(21) SN18000204
- Serial No. SN15000409
- SN19000272
- SN19000213
- 10001077
- SN20000097
- SN16000074
- SN15000238
Distribution
Distributed nationwide across the United States.
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