FDA Device recall Z-0867-2022
MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
- FDA Device
- Class II
- ongoing
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 by Shimadzu Medical Systems, citing it was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting crit….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0867-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-10 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Shimadzu Medical Systems |
| Distribution | AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WV |
Product
MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
Reason
It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.
Identifiers
| code_info | Model: FLUOROspeed X1 Generator Number: D150-40 Serial Numbers: MQ493E19C001 MQ493E3B8002 MQ493E3B9001 MQ493E1B40…Model: FLUOROspeed X1 Generator Number: D150-40 Serial Numbers: MQ493E19C001 MQ493E3B8002 MQ493E3B9001 MQ493E1B4001 MQ493E1A1003 MQ493E1A3001 MQ493E1B5001 MQ493E3B8001 MQ493E1A5001 MQ493E1A1005 MQ493E1A2001 MQ493E1A4001 MQ493E1B6002 MQ493E1A8001 MQ493E1B4002 MQ493E1A4003 MQ493E1A4002 MQ493E1B6001 MQ493E1A2002 MQ493E1AC001 MQ493E1A1002 MQ493E19C002 MQ493E1A3003 MQ493E1A1004 MQ493E1A3002 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0867-2022%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.