The Recall Desk
HighFDA (Devices)·Z-0277-2024·Announced 2023-11-15

Radiographic Imaging System Recall Due to Ceiling Mount Failure Risk

Philips DigitalDiagnost C90 Release 3 ceiling-mounted imaging system faces potential suspension failure risk. The FDA issued a Class II recall for nationwide-distributed Model 712025 due to risk of equipment falling.

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 a Class II recall for a medical device with potential mechanical failure risk. No injuries or deaths have been reported, but the potential for falling equipment poses a risk of harm. Per the rubric, risk-of-harm products without reported injury are scored as High (3).

Plain-English summary

DigitalDiagnost C90 Release 3 is a ceiling-mounted digital radiographic imaging system used to acquire, process, store, display, and export digital radiographic images. The FDA issued a Class II recall for the unit with Model No. 712025, Serial No. SN13000328, due to potential failure of the ceiling suspension system that could cause the equipment to fall.

Facilities with the recalled unit should immediately contact Philips North America LLC or the FDA to assess the equipment and determine appropriate remedial steps.

The recalled product

Product
DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images.
Manufacturer
Philips North America Llc
Category
Medical Device — Radiographic Imaging System
Hazard
  • equipment-fall
  • suspension-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 (2)

  • Model No. 712025
  • Serial No. SN13000328.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category