FDA Device recall Z-1152-2024

Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system

FDA Device
Class II
ongoing
Published 2024-02-28

On 2024-02-28 the FDA classified a Class II recall of Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system by Philips Medical Systems Nederland B V, citing disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1152-2024
Classification	Class II
Status	ongoing
Initiated	2024-01-02
Published	2024-02-28
Last updated	2026-09-13 11:57 UTC
Company	Philips Medical Systems Nederland B V
Distribution	US

Product

Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;

Reason

Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.

Identifiers

code_info	Azurion 3 M12 722063 - UDI-DI 00884838085275 or 00884838086777 Serial Numbers 108 122 131 132 56 64 84 96 98 , 722221 -… Azurion 3 M12 722063 - UDI-DI 00884838085275 or 00884838086777 Serial Numbers 108 122 131 132 56 64 84 96 98 , 722221 - UDI-DI 00884838099203 Serial Numbers 19 3 6 7 9 ; Azurion 3 M15 722064 - UDI-DI 00884838085282 Serial Numbers 201 209 218 229 238 258 259 260 261 267 270 291 314 335 64 , 722222 - UDI-DI 00884838099210 Serial Numbers 12 15 17 19 23 ; Azurion 5 M20 722228 - UDI-DI 00884838099234 Serial Numbers 10 17 18 23 24 25 26 29 38 49 62 ; Azurion 7 B12 722067 - UDI-DI 00884838059290, 00884838064775, or 00884838085350 Serial Numbers 103 104 109 114 115 123 131 132 133 141 147 148 150 163 172 173 190 192 208 214 221 225 234 244 250 26 277 278 36 41 42 46 57 69 70 71 75 81 92 98 , 722225 - UDI-DI 00884838099265 Serial Numbers 28 29 37 41 53 72 ; Azurion 7 B20 722068 - UDI-DI 00884838059207, 00884838064775, 00884838085367, or 00884838101883 Serial Numbers 101 103 104 107 109 110 111 113 114 117 130 136 137 143 146 147 149 150 153 170 172 178 184 196 205 213 225 232 239 243 247 251

code_info

Azurion 3 M12 722063 - UDI-DI 00884838085275 or 00884838086777 Serial Numbers 108 122 131 132 56 64 84 96 98 , 722221 -…

Azurion 3 M12 722063 - UDI-DI 00884838085275 or 00884838086777 Serial Numbers 108 122 131 132 56 64 84 96 98 , 722221 - UDI-DI 00884838099203 Serial Numbers 19 3 6 7 9 ; Azurion 3 M15 722064 - UDI-DI 00884838085282 Serial Numbers 201 209 218 229 238 258 259 260 261 267 270 291 314 335 64 , 722222 - UDI-DI 00884838099210 Serial Numbers 12 15 17 19 23 ; Azurion 5 M20 722228 - UDI-DI 00884838099234 Serial Numbers 10 17 18 23 24 25 26 29 38 49 62 ; Azurion 7 B12 722067 - UDI-DI 00884838059290, 00884838064775, or 00884838085350 Serial Numbers 103 104 109 114 115 123 131 132 133 141 147 148 150 163 172 173 190 192 208 214 221 225 234 244 250 26 277 278 36 41 42 46 57 69 70 71 75 81 92 98 , 722225 - UDI-DI 00884838099265 Serial Numbers 28 29 37 41 53 72 ; Azurion 7 B20 722068 - UDI-DI 00884838059207, 00884838064775, 00884838085367, or 00884838101883 Serial Numbers 101 103 104 107 109 110 111 113 114 117 130 136 137 143 146 147 149 150 153 170 172 178 184 196 205 213 225 232 239 243 247 251

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1152-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.