DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted… — Class II medical device recall Z-3245-2018
Terminated recall by Agfa N.V., reported 2018-10-03, distributed nationwide. A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. Th
| Recall number | Z-3245-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Agfa N.V., Mortsel, Belgium |
| Recall initiated | 2018-08-15 |
| Classified | 2018-09-25 |
| Reported by FDA | 2018-10-03 |
| Terminated | 2020-06-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 108 |
| Reason classes | device malfunction |
| Serial numbers | A5430000015, A5430000020, A5430000030, A5430000042, A5430000045, A5430000052, A5430000053, A5430000054, A5430000057, A5430000058, A5430000060, A5430000061, A5430000063, A5430000066, A5430000067, A5430000068, A5430000074, A5430000079, A5430000081, A5430000085, A5430000089, A5430000095, A5430000096, A5430000100, A5430000105 and 83 more |
Product
DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.
Reason for recall
A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to a mandatory review of all systems, changing the pulley and cables if any deterioration in the cables or irregular or excessive pulley wear. If the two cables that support the equipment to its roof anchor break, the equipment might fall and cause harm to the patient, or others.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3245-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.