Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 29, 2017
Hitachi Oasis MRI System
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Hitachi Medical Systems America Inc recalled Hitachi Oasis MRI System - a moderate-severity action.
Hitachi Oasis MRI System was recalled by Hitachi Medical Systems America Inc in March 29, 2017. Reason: Image data transferred from the MRI system to a workstation showed errors on the slice position reference ima…. Check the official notice for the remedy. Verify recall #Z-1540-2017 with the FDA Devices before acting.
The recall
Hitachi Medical Systems America Inc issued this moderate-severity FDA Devices recall-Image data transferred from the MRI system to a workstation showed errors on the slice position reference ima….
- Moderate
- severity level
- 210 units
- affected scope
- Class II
- classification
- March 29, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1540-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1540-2017) was formally reported on March 29, 2017, with the manufacturer initiating the action on April 16, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Hitachi Medical Systems America Inc is listed as the recalling firm, operating out of Twinsburg, OH. Federal records list the affected scope as 210 units.
The documented reason for this recall is: Image data transferred from the MRI system to a workstation showed errors on the slice position reference image. Distribution data in the federal record shows the product reached: US nationwide distribution. The products were distributed to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK,…. 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
210 units
Related Recalls
6
3 from same agency
Product description
Hitachi Oasis MRI System
Reason for recall
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1540-2017 |
| Date reported | March 29, 2017 |
| Date initiated | April 16, 2015 |
| Recalling firm | Hitachi Medical Systems America Inc |
| Firm location | Twinsburg, OH |
| Affected scope | 210 units |
| Distribution | US nationwide distribution. The products were distributed to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC,… |
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-1540-2017) 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? ▼
Hitachi Oasis MRI System. Recalled by Hitachi Medical Systems America Inc. Units affected: 210 units.
Why was this product recalled? ▼
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 29, 2017. Severity: Moderate. Recall number: Z-1540-2017.
Where was the recalled product distributed? ▼
Distribution: US nationwide distribution. The products were distributed to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. There are four (4) government accounts for this recall: VA Medical Center/Lyster Army Health Clinic, Building 301 - Andrews Avenue, Fort Rucker, AL 36362; Parma VA Medical Center, 8787 Brookpark Rd, Parma, OH 44129; Viera VA Outpatient Clinic, 2900 Veterans Way, Viera, FL 32940; Perry Point VA Medical Center, Avenue D, Suite 1A-120, Perry Point, MD 21902. There are zero (0) Canada accounts for this recall. There are two (2) Mexico accounts for this recall: Hospital General Tipo "B" de Alta Especialidad - SMH, "Fraccionamiento 1 De La Parcela 101, Del Ejido De Atapaneo", Morelia, MX 58300; Hospital General de Occidente, Zoquipan 1050 Avenue, Zapopan Jalisco, MX 45170 The product was distributed to the following countries: Brazil..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1540-2017) 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 March 29, 2017. 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.