Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 5, 2012
Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.
1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) ar…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Toshiba American Medical Systems Inc recalled Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. T… - a moderate-severity action.
Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. T… was recalled by Toshiba American Medical Systems Inc in September 5, 2012. Reason: 1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired i…. Check the official notice for the remedy. Verify recall #Z-2282-2012 with the FDA Devices before acting.
The recall
Toshiba American Medical Systems Inc issued this moderate-severity FDA Devices recall-1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired i….
- Moderate
- severity level
- Class II
- classification
- September 5, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2282-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2282-2012) was formally reported on September 5, 2012, with the manufacturer initiating the action on July 13, 2009. It is classified under Moderate severity (Class II), with a current status of Terminated. Toshiba American Medical Systems Inc is listed as the recalling firm, operating out of Tustin, CA. Federal records list the affected scope as 24 Systems.
The documented reason for this recall is: 1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time… Distribution data in the federal record shows the product reached: Nationwide distribution: USA including states of: AL, AR, CA, CO, FL, GA, KY, MA, MD, MT, ND, NJ, NV, NY, OH, PA and Puerto Rico.. 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
24 Systems
Related Recalls
6
3 from same agency
Product description
Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.
Reason for recall
1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning, while all related information is displayed on the reco
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2282-2012 |
| Date reported | September 5, 2012 |
| Date initiated | July 13, 2009 |
| Recalling firm | Toshiba American Medical Systems Inc |
| Firm location | Tustin, CA |
| Affected scope | 24 Systems |
| Distribution | Nationwide distribution: USA including states of: AL, AR, CA, CO, FL, GA, KY, MA, MD, MT, ND, NJ, NV, NY, OH, PA and Puerto Rico. |
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-2282-2012) 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? ▼
Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.. Recalled by Toshiba American Medical Systems Inc. Units affected: 24 Systems.
Why was this product recalled? ▼
1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning, while all related information is displayed on the reco
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 5, 2012. Severity: Moderate. Recall number: Z-2282-2012.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution: USA including states of: AL, AR, CA, CO, FL, GA, KY, MA, MD, MT, ND, NJ, NV, NY, OH, PA and Puerto Rico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2282-2012) 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 September 5, 2012. 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.