Agfa Healthcare Recalls DX-D 600 Imaging Packages Due to Crane Movement
Agfa Healthcare is recalling 17 DX-D 600 imaging packages because the overhead tube crane may move uncontrolled. Customers should stop using the equipment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II, and the uncontrolled movement of the overhead crane presents a risk of harm to patients or staff, although no specific injuries are reported in the source text.
Plain-English summary
Agfa Healthcare Corp. is recalling 17 units of the DX-D 600 DXD Imaging Package. The recall was initiated because customers reported that the Overhead Tube Crane (OTC) exhibited increased velocity and uncontrolled longitudinal movement during room or exam preparation.
The affected units were distributed worldwide, including in the United States (specifically in Georgia, Indiana, Kansas, Kentucky, Massachusetts, New Jersey, South Carolina, Virginia, and the District of Columbia) and Canada. The specific serial numbers for the recalled units are A5430000089, A5430000131, A5430000015, A5430000095, A5430000052, A5430000061, A5430000079, A5430000030, A5430000042, A5430000066, A5430000081, A5430000085, A5430000096, A5430000020, A5430000067, A5430000125, and A5430000105.
Customers should stop using the affected equipment and contact Agfa Healthcare Corp. for further instructions on the recall.
The recalled product
- Product
- DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and…
- Manufacturer
- AGFA Healthcare Corp.
- Affected units
- 17
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 (17)
- Serial Nos. A5430000089
- A5430000131
- A5430000015
- A5430000095
- A5430000052
- A5430000061
- A5430000079
- A5430000030
- A5430000042
- A5430000066
- A5430000081
- A5430000085
- A5430000096
- A5430000020
- A5430000067
- A5430000125
- A5430000105
Distribution
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