Swissray Medical Recalls ddR Formula B X-ray Systems for Movement and Calibration Issues

Plain-English summary

Swissray Medical is recalling 26 units of the ddR Formula B X-ray System in the United States. The recall was initiated because the devices may experience movement of the arm, loss of calibration, and loss of communication. These malfunctions present a risk of possible injury to patients or operators.

The affected units are distributed nationwide and are identified by specific serial numbers listed in the recall documentation. The X-ray systems are used for medical imaging. The recall covers both units in U.S. commerce and those outside of U.S. commerce, with the specific serial numbers provided in the agency's structured data.

Healthcare facilities and users of these devices should stop using the affected X-ray systems immediately. Swissray Medical is the recalling firm and is responsible for managing the recall process. Users should contact the manufacturer or follow the instructions provided by the FDA to resolve the safety issue.

The recalled product

Product

ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging

Manufacturer

Swissray Medical

Category

Medical Device — X-ray System

Hazard

• injury
• mechanical-failure
• calibration-loss

Affected units

26

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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