Agency classClass IIOur severity:High FDA (Devices)·Z-2307-2016·Announced 2016-08-10

Philips MultiDiagnost Eleva X-Ray System Recalled for Bolt Failure Risk

Philips is recalling 993 MultiDiagnost Eleva x-ray systems because bolts may break, causing the C-arm to sag. The recall covers units distributed worldwide.

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 recall involves a structural defect in a medical device that could cause the C-arm to sag, posing a risk of harm. No injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Philips Electronics North America Corporation is recalling 993 units of the MultiDiagnost Eleva x-ray system (Product Codes 708032 and 708036). The recall is due to a defect where the two bolts attaching the clamping plate to the lateral shaft may break.

If these bolts break, the C-arm could move laterally forward, slide out of its bearings, and sag. This presents a risk of injury to patients or staff if the equipment fails during use.

The affected units were distributed worldwide, including in the United States, Canada, and numerous other countries. Users should contact Philips for instructions on how to address the defect.

The recalled product

Product: MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — Diagnostic Imaging
Hazard: structural-failure
falling-object
Affected units: 993

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)

All serial numbers. 708032 System Serial numbers 100
198
354
104
367
68
428
183
414
355
289
32
269
361
160
423
50
56
205
350

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Philips Electronics North America Corporation 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 3 products in this recall →

Same manufacturer · Philips Electronics North America Corporation

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Same hazard · structural failure