The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0276-2024·Announced 2023-11-15

DigitalDiagnost C90 radiographic system poses ceiling-mount failure risk

Philips DigitalDiagnost C90 ceiling-mounted radiographic systems may fail and fall. FDA Class II recall affects 143 units nationwide; facilities should contact Philips.

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: FDA Class II recall for a risk-of-harm medical device with a potential structural failure hazard. The source describes potential for ceiling-mounted units to fail and fall, with no reported injuries, meeting the 'High' severity criteria.

Plain-English summary

The FDA has recalled 143 units of the Philips DigitalDiagnost C90 High Performance radiographic imaging system. These ceiling-mounted units have a potential to fail and fall.

This Class II recall affects healthcare facilities nationwide that have installed DigitalDiagnost C90 systems with the specified model and serial numbers.

Healthcare facilities with affected units should contact Philips North America Llc for further guidance on inspection, maintenance, or replacement measures.

The recalled product

Product
DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.
Manufacturer
Philips North America Llc
Category
Medical Device — Radiographic Imaging System
Hazard
Affected units
143

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. 712034
  • UDI:(01)00884838090699(21)SN19000013
  • (01)00884838090699(21)10000203
  • (01)00884838090699(21)10000008
  • (01)00884838090699(21)10000030
  • (01)00884838090699(21)10000043
  • (01)00884838090699(21)10000037
  • (01)00884838090699(21)19861128
  • (01)00884838090699(21)19861129
  • (01)00884838090699(21)10000064
  • (01)00884838090699(21)19861143
  • (01)00884838090699(21)10000024
  • (01)00884838090699(21)SN10001001
  • (01)00884838090699(21)10001043
  • (01)00884838090699(21)10000077
  • (01)00884838090699(21)10000076
  • (01)00884838090699(21)10000104
  • (01)00884838090699(21)10000102
  • (01)00884838090699(21)10000126
  • (01)00884838090699(21) 10000185

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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