The Recall Desk
HighFDA (Devices)·Z-0272-2024·Announced 2023-11-15

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
Category
Medical Device — Radiographic Imaging Equipment
Hazard
Affected units
13

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.

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.

See all 10 products in this recall →

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