The Recall Desk
HighFDA (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.

What this means for you

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
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 →

Related recalls

Same manufacturer · Philips Electronics North America Corporation

See all →

Same hazard · structural failure

See all →