MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 — Class II medical device recall Z-0867-2022
Ongoing recall by Shimadzu Medical Systems, reported 2022-04-13, distributed in AK, AR, AZ, CA, CO, CT, FL, GA…. It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in som
| Recall number | Z-0867-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Shimadzu Medical Systems, Torrance, CA, United States |
| Recall initiated | 2022-01-10 |
| Classified | 2022-04-06 |
| Reported by FDA | 2022-04-13 |
| Distributed | 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 |
| Quantity | 25 systems |
| Serial numbers | MQ493E19C001, MQ493E19C002, MQ493E1A1002, MQ493E1A1003, MQ493E1A1004, MQ493E1A1005, MQ493E1A2001, MQ493E1A2002, MQ493E1A3001, MQ493E1A3002, MQ493E1A3003, MQ493E1A4001, MQ493E1A4002, MQ493E1A4003, MQ493E1A5001, MQ493E1A8001, MQ493E1AC001, MQ493E1B4001, MQ493E1B4002, MQ493E1B5001, MQ493E1B6001, MQ493E1B6002, MQ493E3B8001, MQ493E3B8002, MQ493E3B9001 |
Product
MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
Reason for recall
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.
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-0867-2022. 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.