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Recall Observatory FDA recall evidence

Device product

DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.

Z-0272-2024

September 21, 2023

Class II

Product summary

Firm
Philips North America Llc
Event
Event 93200
Status
Ongoing
Classification
Class II
Quantity
13 units
Official record key
device-enforcement:Z-0272-2024

Official wording

Reason: Potential for units suspended on the ceiling to fail and fall.

Code information: 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, SN16000075, SN15000367, SN18000428, SN17000318, SN18000309, SN18000204.

Distribution pattern: Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for units suspended on the ceiling to fail and fall.