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.
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 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
- Affected units
- 1
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.
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 →Related recalls
Same manufacturer · Philips North America Llc
See all →- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- ModeratePhilips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips MR 7700 MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
- ModeratePhilips MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
Same hazard · equipment fall
See all →- HighGE Healthcare Allia IGS 7 X-ray Systems Adhesive Bolt Failure Recall
FDA (Devices) · 2024-05-15
- HighGE Allia IGS Fluoroscopic X-Ray Systems Adhesive Bolt Defect
FDA (Devices) · 2024-05-15
- HighGE Healthcare Allia IGS Fluoroscopic Systems Recall: Missing Adhesive
FDA (Devices) · 2024-05-15
- HighGE Innova IGS Fluoroscopic X-Ray Systems Adhesive Defect Recall
FDA (Devices) · 2024-05-15
- HighMaquet Blueline Series OR Light Systems Recalled Due to Fall Risk
FDA (Devices) · 2024-01-24
Similar recalls
- HighPhilips DigitalDiagnost C50 Radiographic System Ceiling Suspension Malfunction Risk
FDA (Devices) · 2023-04-19
- ModerateDigitalDiagnost C90 systems recalled over ceiling carriages resisting vertical movement
FDA (Devices) · 2025-11-19
- HighPhilips DigitalDiagnost Release 3 Footplate Hook Recall for Injury Risk
FDA (Devices) · 2018-08-29
- SeverePhilips DigitalDiagnost Release 3 Footplate Hook Recall
FDA (Devices) · 2018-08-29
- HighX-ray imaging system ceiling suspension may descend without adequate maintenance
FDA (Devices) · 2023-04-19
- HighPhilips Digital Diagnost Radiographic System Recall Due to Footboard Defect
FDA (Devices) · 2014-04-30