Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported April 27, 2022
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Medical Solutions USA, Inc recalled SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 1… - a moderate-severity action.
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 1… was recalled by Siemens Medical Solutions USA, Inc in April 27, 2022. Reason: Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notif…. Check the official notice for the remedy. Verify recall #Z-0962-2022 with the FDA Devices before acting.
The recall
Siemens Medical Solutions USA, Inc issued this moderate-severity FDA Devices recall-Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notif….
- Moderate
- severity level
- 547 units
- affected scope
- Class II
- classification
- April 27, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0962-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0962-2022) was formally reported on April 27, 2022, with the manufacturer initiating the action on March 7, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Siemens Medical Solutions USA, Inc is listed as the recalling firm, operating out of Malvern, PA. Federal records list the affected scope as 547 units US.
The documented reason for this recall is: Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows. Result… Distribution data in the federal record shows the product reached: Nationwide. 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
547 units US
Related Recalls
6
3 from same agency
Product description
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
Reason for recall
Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows. Results in potential patient issues: Possible rescan , Unexpected X-Ray dose and additional contrast media, Delay in diagnosis, scan abort,and patient rescan
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0962-2022 |
| Date reported | April 27, 2022 |
| Date initiated | March 7, 2022 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Firm location | Malvern, PA |
| Affected scope | 547 units US |
| Distribution | Nationwide |
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-0962-2022) 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? ▼
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 547 units US.
Why was this product recalled? ▼
Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows. Results in potential patient issues: Possible rescan , Unexpected X-Ray dose and additional contrast media, Delay in diagnosis, scan abort,and patient rescan
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 27, 2022. Severity: Moderate. Recall number: Z-0962-2022.
Where was the recalled product distributed? ▼
Distribution: Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0962-2022) 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.
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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 April 27, 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 July 2026.