The Recall Desk
ModerateFDA (Devices)·Z-1829-2012·Announced 2012-06-27

Philips MultiDiagnost Eleva X-Ray System Cable Damage Recall

Philips Healthcare is recalling 433 MultiDiagnost Eleva X-ray systems worldwide due to potential damage to system cables from repeated movement.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, significant injuries, or fatalities, aligning with the criteria for a moderate severity score.

Plain-English summary

Philips Healthcare Inc. is recalling 433 units of the MultiDiagnost Eleva and MultiDiagnost Eleva II X-ray systems. The affected products include units with product codes 708032, 708034, 708036, and 708037, specifically those equipped with swivel cables delivered from 2007. These systems are multifunctional devices used for general radiography, fluoroscopy, and angiography across various medical specialties.

The recall was initiated because the system cables may have damage resulting from repeated movement. This defect could potentially compromise the integrity of the equipment during use. The affected units were distributed nationwide in the United States and in numerous foreign countries, including Australia, Canada, China, Germany, and the United Kingdom.

Healthcare facilities and users of these systems should stop using the affected units and contact Philips Healthcare Inc. for further instructions on repair or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector with swivel cable Product Codes: 708034, 708037 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/ universal system. Gen
Affected units
433

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 (1)

  • Units with cable swivel delivered from 2007

Distribution

Distributed nationwide across the United States.