Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported December 16, 2020
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.
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Shimadzu Medical Systems recalled Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle … - a moderate-severity action.
Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle … was recalled by Shimadzu Medical Systems in December 16, 2020. Reason: There is a potential that the adjustable handle option on the X-Ray system may have been installed with impro…. Check the official notice for the remedy. Verify recall #Z-0534-2021 with the FDA Devices before acting.
The recall
Shimadzu Medical Systems issued this moderate-severity FDA Devices recall-There is a potential that the adjustable handle option on the X-Ray system may have been installed with impro….
- Moderate
- severity level
- 115 units
- affected scope
- Class II
- classification
- December 16, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0534-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0534-2021) was formally reported on December 16, 2020, with the manufacturer initiating the action on November 9, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Shimadzu Medical Systems is listed as the recalling firm, operating out of Torrance, CA. Federal records list the affected scope as 115 units.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MI, MN, MS, NC, ND, NE, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
115 units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0534-2021 |
| Date reported | December 16, 2020 |
| Date initiated | November 9, 2020 |
| Recalling firm | Shimadzu Medical Systems |
| Firm location | Torrance, CA |
| Affected scope | 115 units |
| Distribution | US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MI, MN, MS, NC, ND, NE, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0534-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Shimadzu Medical Systems. Units affected: 115 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 16, 2020. Severity: Moderate. Recall number: Z-0534-2021.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MI, MN, MS, NC, ND, NE, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0534-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 16, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.