The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0275-2024·Announced 2023-11-15

Philips DigitalDiagnost C90 Radiographic Systems Recalled for Ceiling Mount Failure

Philips is recalling 33 DigitalDiagnost C90 radiographic imaging systems nationwide due to potential structural failure of ceiling-mounted units. Equipment may fall, creating injury risk.

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: The recall addresses a structural failure risk in a medical device where falling equipment could cause serious injury. Although the FDA classified this as Class II and no injuries have been reported, the hazard is theoretical with no reported incidents, placing it in the High category as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Philips North America LLC is recalling the DigitalDiagnost C90 Flex, Value, Chest, and ER models, which are used to acquire, process, store, display, and export digital radiographic images. Thirty-three units have been distributed nationwide.

The equipment is ceiling-mounted and presents a potential structural failure risk. Affected units may fail and fall from their ceiling mounts, creating a hazard of falling equipment and potential injury to patients and medical personnel in healthcare facilities.

Affected medical facilities should immediately cease use of the recalled equipment and contact Philips for remediation options. The FDA classified this as a Class II recall.

The recalled product

Product
DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.
Manufacturer
Philips North America Llc
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
33

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. 712035
  • UDI: (01)00884838090705(21)10000009
  • (01)00884838090705(21)10000010
  • (01)00884838090705(21)10000003
  • (01)00884838090705(21)10000004
  • (01)00884838090705(21)10000002
  • (01)00884838090705(21)10000001
  • (01)00884838090705(21)10000053
  • (01)00884838090705(21) 10001042
  • (01)00884838090705(21) 10001044
  • (01)00884838090705(21) 10001125
  • (01)00884838090705(21) 10001113
  • (01)00884838090705(21) 10001111
  • (01)00884838090705(21) 10001112
  • (01)00884838090705(21) 10001109
  • (01)00884838090705(21) 10001110
  • (01)00884838090705(21) 10001114
  • (01)00884838090705(21) 21862107
  • (01)00884838090705(21) 10001130
  • (01)00884838090705(21) 21862103

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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