The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0279-2024·Announced 2023-11-15

Philips radiographic imaging system ceiling units risk of falling

Philips EasyDiagnost Eleva DRF digital radiographic systems mounted on ceilings may fail and fall. 40 units nationwide are being recalled due to potential ceiling mount failure.

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 is an FDA Class II recall of medical equipment with potential for mechanical failure and falling hazards. The source text contains no reports of injuries or illnesses. The hazard is characterized as a potential risk rather than confirmed incidents, meeting the criterion for High severity: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips North America LLC is recalling the EasyDiagnost Eleva DRF, Release 5, a digital radiographic imaging system used to acquire, process, store, display and export digital radiographic images. The recalled equipment includes Model No. 706050, with 40 units distributed nationwide.

These units are designed to be suspended from ceilings in healthcare facilities. The FDA has identified a potential for the ceiling-mounted units to fail and fall, which could create a hazard to patients and healthcare staff in the area below the equipment.

Healthcare facilities that have received this equipment should contact Philips North America LLC to determine whether their units are affected by this recall and to arrange appropriate corrective action.

The recalled product

Product
EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.
Manufacturer
Philips North America Llc
Category
Medical Device — Diagnostic Imaging Equipment
Hazard
Affected units
40

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. 706050
  • UDI: (01)00884838074255(21) SN17000007
  • (01)00884838074255(21) SN16000025
  • (01)00884838074255(21) SN15000051
  • (01)00884838074255(21) SN15000049
  • (01)00884838074255(21) SN15000056
  • (01)00884838074255(21) SN15000055
  • (01)00884838074255(21) SN16000046
  • (01)00884838074255(21) SN16000041
  • (01)00884838074255(21) SN16000011
  • (01)00884838074255(21) SN16000029
  • (01)00884838074255(21) SN16000024
  • (01)00884838074255(21) SN16000028
  • (01)00884838074255(21) SN16000042
  • (01)00884838074255(21) SN16000030
  • (01)00884838074255(21) SN16000044
  • (01)00884838074255(21) SN16000051
  • (01)00884838074255(21) SN17000001
  • (01)00884838074255(21) SN16000049
  • (01)00884838074255(21) SN16000043

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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