The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0271-2024·Announced 2023-11-15

Philips CombiDiagnost R90 radiography systems recalled for ceiling mount failure

Philips is recalling 46 CombiDiagnost R90 radiography systems nationwide due to potential ceiling mount failure that could allow suspended units to fall, posing an 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: This Class II medical device recall involves a structural defect with potential for serious injury from falling ceiling-mounted equipment. Since no injuries have been reported and the hazard is potential rather than confirmed, this fits the rubric criterion 'risk-of-harm products where injury has not yet been reported,' warranting a High severity rating.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 46 CombiDiagnost R90 Radiography and Fluoroscopy (R/F) systems manufactured by Philips North America LLC. The affected units use Model Numbers 709030 and 709031 and were distributed nationwide.

The ceiling-mounted diagnostic systems have a potential structural defect that could cause the suspended units to fail and fall. This poses a risk of injury to patients and healthcare personnel in the vicinity of the equipment. No injuries have been reported.

Healthcare facilities should immediately check the provided serial numbers to determine if their CombiDiagnost R90 system is affected by this recall. Any facility with affected equipment should cease using the system immediately.

Contact Philips North America LLC for instructions on repair, replacement, or safe decommissioning of the recalled units.

The recalled product

Product
CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
Manufacturer
Philips North America Llc
Category
Medical Device — Diagnostic Radiography System
Hazard
Affected units
46

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. 709030 and 709031
  • UDI: (01)00884838076747(21) SN17000014
  • (01)00884838076747(21) 10000020
  • (01)00884838076747(21) SN17000130
  • (01)00884838076747(21) SN17000123
  • (01)00884838076747(21) SN18000021
  • (01)00884838076747(21) SN18000001
  • (01)00884838076747(21) SN18000075
  • (01)00884838076747(21) SN18000002
  • (01)00884838076747(21) 10000004
  • (01)00884838076747(21) SN17000144
  • (01)00884838076747(21) SN17000140
  • (01)00884838076747(21) SN18000003
  • (01)00884838076747(21) SN18000063
  • (01)00884838076747(21) SN18000018
  • (01)00884838076747(21) SN18000022
  • (01)00884838076747(21) SN18000041
  • (01)00884838076747(21) SN18000031
  • (01)00884838076747(21) 10001097
  • (01)00884838076747(21) 10000056

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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