The Recall Desk
SevereFDA (Devices)·Z-2300-2018·Announced 2018-07-04

Philips OmniDiagnost-Eleva X-ray System Recalled Due to Table Rotation Hazard

Philips is recalling 508 OmniDiagnost-Eleva X-ray systems because a broken actuator fixation can cause the table to rotate uncontrollably, posing a risk of injury.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect in a medical device that can cause high-speed, uncontrollable movement, posing a significant risk of injury to patients and staff.

Plain-English summary

Philips Medical Systems Nederlands is recalling 508 units of the OmniDiagnost-Eleva X-ray system (Product Nos. 708026, 708027, 708028). The recall was initiated because the fixation of the upper and lower tilt actuator may break off. If this occurs, the table can start to rotate from 0 to +90/-90 degrees at high speed. This rotating movement cannot be stopped by the user.

The uncontrolled rotation creates a potential for patients to fall off the table. This poses a risk of injury to the patient, the user, or any bystanders present. The affected equipment was distributed nationwide in the United States.

Healthcare facilities should identify affected units by checking the As-Maintained System Equipment Number against the list provided in the official recall notice. Users should contact Philips Medical Systems Nederlands for instructions on how to address the defect.

The recalled product

Product
OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028
Affected units
508

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Philips Medical Systems Nederlands 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 Medical Systems Nederlands

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