Shimadzu Mobile X-Ray System — Class II medical device recall Z-0534-2021
Ongoing recall by Shimadzu Medical Systems, reported 2020-12-16, distributed nationwide. There is a potential that the adjustable handle option on the X-Ray system may have been installed with improp
| Recall number | Z-0534-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shimadzu Medical Systems, Torrance, CA, United States |
| Recall initiated | 2020-11-09 |
| Classified | 2020-12-04 |
| Reported by FDA | 2020-12-16 |
| Distributed | Nationwide (US) |
| Quantity | 115 units |
| Serial numbers | 41E09E963008, 41F41DD7C002, 41F41DD7C003, 41F41DD7C004, 41F41DD7C005, 41F41DD7C006, 41F41DD7C007, 41F41DD81001, 41F41DD81002, 41F41DD81003, 41F41DD81005, 41F41DD81010, 41F41DD82008, 41F41DD82009, 41F41DD82010, 41F41DD82011, 41F41DD83001, 41F41DD83002, 41F41DD83003, 41F41DD83004, 41F41DD83005, 41F41DD83007, 41F41DD83008, 41F41DD83009, 41F41DD83015 and 199 more |
Product
Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
Reason for recall
There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of individuals around the device.
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-0534-2021. 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.