Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported April 13, 2022
MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
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…
Shimadzu Medical Systems recalled MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 - a moderate-severity action.
MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 was recalled by Shimadzu Medical Systems in April 13, 2022. Reason: It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in so…. Check the official notice for the remedy. Verify recall #Z-0867-2022 with the FDA Devices before acting.
The recall
Shimadzu Medical Systems issued this moderate-severity FDA Devices recall-It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in so….
- Moderate
- severity level
- Class II
- classification
- April 13, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0867-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0867-2022) was formally reported on April 13, 2022, with the manufacturer initiating the action on January 10, 2022. 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 25 systems.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: U.S.: 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, and WV. O.U.S.: N/A. 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, 6 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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
25 systems
Related Recalls
6
6 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0867-2022 |
| Date reported | April 13, 2022 |
| Date initiated | January 10, 2022 |
| Recalling firm | Shimadzu Medical Systems |
| Firm location | Torrance, CA |
| Affected scope | 25 systems |
| Distribution | U.S.: 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, and WV. O.U.S.: N/A |
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-0867-2022) 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? ▼
MODEL: X-RAY R/F SYSTEM FLUOROspeed X1. Recalled by Shimadzu Medical Systems. Units affected: 25 systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 13, 2022. Severity: Moderate. Recall number: Z-0867-2022.
Where was the recalled product distributed? ▼
Distribution: U.S.: 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, and WV. O.U.S.: N/A.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0867-2022) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
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Compare this recall with FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access… →
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 April 13, 2022. 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 August 2026.