The Recall Desk
HighFDA (Devices)·Z-0273-2024·Announced 2023-11-15

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.

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 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
Category
Medical Device — Radiographic Imaging System
Hazard
  • fall-hazard
  • ceiling-mounting-failure

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.

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