Agency classClass IIOur severity:High FDA (Devices)·Z-2305-2016·Announced 2016-08-10

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

Philips is recalling 993 MultiDiagnost Eleva x-ray systems because bolts attaching the clamping plate may break, causing the C-arm to sag.

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, but the source text does not report any injuries or illnesses.

Plain-English summary

Philips Electronics North America Corporation is recalling 993 units of the MultiDiagnost Eleva with Flat Detector x-ray system (Product Codes 708034, 708037, 708038). The recall was initiated because the two bolts that attach 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. The affected units were distributed worldwide, including in the United States, Canada, and numerous other countries.

Healthcare facilities should contact Philips to arrange for the necessary corrective actions. Users should verify their system serial numbers against the provided lists to determine if their equipment is affected.

The recalled product

Product: MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — X-Ray System
Hazard: structural-failure
equipment-malfunction
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. 708034 System serial numbers 6
264
112
106
233
136
31
83
224
144
71
123
5
249
134
103
266
97
132
61

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