FDA Device recall Z-3245-2018
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 me…
- FDA Device
- Class II
- terminated
- Published 2018-10-03
On 2018-10-03 the FDA classified a Class II recall of 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 me… by Agfa N V, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3245-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-15 |
| Published | 2018-10-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Agfa N V |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial Nos: A5430000015 A5430000020 A5430000030 A5430000042 A5430000045 A5430000052 A5430000053 A5430000054 A54…Serial Nos: 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 A5430000106 A5430000107 A5430000108 A5430000119 A5430000121 A5430000124 A5430000125 A5430000130 A5430000131 A5430000132 A5430000133 A5430000137 A5430000143 A5430000144 A5430000149 A5430000156 A5430000162 A5430000165 A5430000166 A5430000172 A5430000176 A5430000177 A5430000183 A5430000184 A5430000199 A5430000206 A5430000207 A5430000215 A5430000218 A5430000222 A5430000224 A5430000225 A5430000226 A5430000228 A5430000229 A5430000234 A5430000237 A5430000238 A5430000242 A5430000246 A5430000247 A5430000248 A5430000249 A5430000263 A5430000264 A5430000272 A5430000275 A5430000276 A5430000279 A5430000281 A5430000285 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3245-2018%22
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