The Recall Desk
SevereFDA (Devices)·Z-2301-2018·Announced 2018-07-04

Philips OmniDiagnost X-ray System Recalled for Tilt Actuator Failure Risk

Philips is recalling 477 OmniDiagnost Classic X-ray systems because a broken tilt actuator could 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 mechanical defect that could cause a patient to fall from a rotating table, posing a significant risk of injury to patients, users, or bystanders, which aligns with the criteria for significant injury reports or high-risk mechanical failures.

Plain-English summary

Philips Medical Systems Nederlands is recalling 477 units of the OmniDiagnost Classic X-ray system (Product Nos. 70859, 708023, 708024, 708025). The recall covers systems distributed nationwide in the United States.

The recall is due to a defect where the fixation of the upper and lower tilt actuator might break off. If this occurs, the table may start to rotate from 0 to +90/-90 degrees at high speed. This rotating movement cannot be stopped by the user, which could potentially lead to a patient falling off the table. There is a risk of injury for the patient, user, or bystander.

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 resolve the issue.

The recalled product

Product
OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
Affected units
477

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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