Agency classClass IIOur severity:High FDA (Devices)·Z-1382-2023·Announced 2023-04-19

Philips DigitalDiagnost C50 Radiographic System Ceiling Suspension Malfunction Risk

The Philips DigitalDiagnost C50 radiographic system's ceiling suspension may descend unintentionally if annual maintenance is skipped and power is interrupted, potentially injuring patients and operators.

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 source describes a Class II device recall with a theoretical risk of injury to patients and operators due to mechanical wear of the spring balancer. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported receive a score of 3.

Plain-English summary

The Philips DigitalDiagnost C50, a radiographic imaging system used for generating medical images, is subject to this recall due to a potential malfunction of its ceiling suspension system.

The issue stems from the telescopic carriage's spring balancer. If the required annual preventive maintenance is not performed as specified in the Instructions for Use, the tension force of the spring balancer will gradually decay due to normal wear. This decay creates a risk that the ceiling suspension may descend unexpectedly if the system loses power, potentially injuring patients and medical staff.

The recall affects 10 units distributed in the United States (including Puerto Rico and the U.S. Virgin Islands) and 570 units distributed internationally across multiple countries. Affected units can be identified by their serial numbers listed in the FDA recall notice.

Users should contact Philips North America LLC to ensure their unit has current annual maintenance and to confirm the system is operating safely. If your facility operates an affected unit, verify that all required preventive maintenance has been completed per the product's Instructions for Use.

The recalled product

Product: Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging
Hazard: equipment-malfunction
fall-hazard
mechanical-wear

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · Philips North America Llc

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