Agency classClass IIOur severity:High FDA (Devices)·Z-0274-2024·Announced 2023-11-15

DigitalDiagnost 4 Radiographic Systems Risk of Ceiling Mount Failure

DigitalDiagnost 4 High Performance radiographic systems may fail and fall from ceiling mounts. The FDA recalls 366 units distributed nationwide.

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: FDA Class II medical device with potential for structural failure of ceiling-mounted equipment. No injuries or failures have been reported in the source material, making this a risk-of-harm scenario with theoretical rather than demonstrated hazard.

Plain-English summary

The U.S. Food and Drug Administration has issued a Class II recall for DigitalDiagnost 4 High Performance radiographic systems manufactured by Philips North America LLC. These medical devices are used to acquire, process, store, display, and export digital radiographic images.

The recall is due to a potential for units suspended on the ceiling to fail and fall. The recall affects 366 units distributed nationwide across model numbers 712027, 712031, and 712226.

The recalled product

Product: DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging
Hazard: fall-hazard
structural-failure
Affected units: 366

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. 712027
712031 & 712226
UDI: (01)00884838065321(21) SN18000276
(01)00884838065321(21) SN18000158
(01)00884838065321(21) SN19000178
(01)00884838065321(21) SN18000227
(01)00884838065321(21) SN18000256
(01)00884838065321(21) SN18000228
(01)00884838065321(21) SN18000257
(01)00884838065321(21) SN18000247
(01)00884838065321(21) SN18000252
(01)00884838065321(21) SN18000238
(01)00884838065321(21) SN19000195
(01)00884838065321(21) SN19000101
(01)00884838065321(21) SN19000180
(01)00884838065321(21) SN18000283
(01)00884838065321(21) SN18000299
(01)00884838065321(21) SN19000337
(01)00884838065321(21) SN18000305
(01)00884838065321(21) SN19000019

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 →

Same manufacturer · Philips North America Llc

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Same hazard · fall hazard