The Recall Desk
HighFDA (Devices)·Z-0280-2024·Announced 2023-11-15

ProxiDiagnost N90 X-ray Systems Recalled for Potential Ceiling Mount Failure

Philips is recalling 101 ProxiDiagnost N90 radiography and fluoroscopy systems due to potential failure of ceiling-mounted units, which could fall and cause injury.

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 is an FDA Class II recall involving a risk-of-harm scenario: potential failure of ceiling-mounted equipment that could fall and cause injury. No injuries or deaths have been reported to date, which places this at High severity per the rubric rather than Severe.

Plain-English summary

Philips North America LLC is recalling approximately 101 ProxiDiagnost N90 Radiography and Fluoroscopy (R/F) systems distributed nationwide. These diagnostic imaging systems are used in medical facilities and hospitals.

The recall is due to potential failure of the ceiling suspension mechanism. Units mounted on the ceiling may fail and fall, creating a risk of injury to patients, healthcare workers, or bystanders in the vicinity.

Consumers who have one of the affected systems should contact Philips North America LLC or the FDA for inspection, repair, or replacement instructions. Do not operate affected equipment until the issue has been resolved.

The recalled product

Product
ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system
Manufacturer
Philips North America Llc
Category
Medical Device — Diagnostic Imaging Equipment
Hazard
  • fall-hazard
  • equipment-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. 706100 & 706110
  • UDI: (01)00884838085619(21) SN18000019
  • (01)00884838085619(21) SN18000019
  • (01)00884838085619(21) SN18000002
  • (01)00884838085619(21) 721815121706
  • (01)00884838085619(21) 10000015
  • (01)00884838085619(21) SN18000014
  • (01)00884838085619(21) 20000070
  • (01)00884838085619(21) SN19000007
  • (01)00884838085619(21) 10000035
  • (01)00884838085619(21) 10000011
  • (01)00884838085619(21) SN18000021
  • (01)00884838085619(21) SN19000002
  • (01)00884838085619(21) SN19000001
  • (01)00884838085619(21) 10000021
  • (01)00884838085619(21) 20000054
  • (01)00884838085619(21) SN19000006
  • (01)00884838085619(21) SN19000011
  • (01)00884838085619(21) SN19000012
  • (01)00884838085619(21) SN19000005

Distribution

Distributed nationwide across the United States.

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