Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640 SOMATOM X.cite - Model 11330001 Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
Class I - DangerousWhat Should You Do?
- Check if you have this product: US Serial Numbers: 111307, 111526, 119328, 108158, 123104, 111219, 123054, 117633, 111566, 111427, 123059, 117558, 117533, 119317, 117647, 108088, 123060, 123118, 123055, 111518, 123113, 108108, 123129, 123122, 123069, 111507, 111560, 119142, 108111, 108062, 119376. Update CT016/21/S is a remote update for the following products with software versions syngo CT VA30A SP2 or syngo CT VA30A SP2a or syngo CT VA30A SP3: SOMATOM go.Now (Model #11061610, #11061612, #11061613, #11061618), SOMATOM go.Up (Model #11061620, #11061622, #11061623, #11061628), SOMATOM go.All (Model #11061630, #11061632, #11061638), SOMATOM go.Top (Model #11061640, #11061642, #11061648), SOMATOM go.Sim (Model #11061660, #11061668), SOMATOM go.Open Pro (Model #11061670, #11061678). Update CT018/21/S is a remote update for the following products with software versions syngo.CT VA20A_SP4a or syngo.CT VA20A_SP5: SOMATOM go.Now (Model #11061610, #11061612, #11061613, #11061618), SOMATOM go.Up (Model #11061620, #11061622, #11061623, #11061628), SOMATOM go.All (Model #11061630, #11061632, #11061638), SOMATOM go.Top (Model #11061640, #11061642, #11061648) without dual energy post-processing. Update CT022/21/S is an onsite update for the following product with software versions syngo.CT VA20A_SP4a or syngo.CT VA20A_SP5: SOMATOM go.Top (Model #11061640, #11061642, #11061648) without dual energy post-processing. Update CT025/21/S is an onsite update for the following product with software versions syngo.CT VA30A_SP2, VA30A_SP2a, syngo CT VA30A_SP3, or syngo CT VA30A_FP2 : SOMATOM X.cite (Model #11330001)
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Siemens Medical Solutions USA, Inc
- Reason for Recall:
- Software versions may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Sporadic software errors may also occur during interventional workflows, resulting in delay in diagnosis or scan aborts with the necessity for patient rescan may occur
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640 SOMATOM X.cite - Model 11330001 Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
Product Codes/Lot Numbers:
US Serial Numbers: 111307, 111526, 119328, 108158, 123104, 111219, 123054, 117633, 111566, 111427, 123059, 117558, 117533, 119317, 117647, 108088, 123060, 123118, 123055, 111518, 123113, 108108, 123129, 123122, 123069, 111507, 111560, 119142, 108111, 108062, 119376. Update CT016/21/S is a remote update for the following products with software versions syngo CT VA30A SP2 or syngo CT VA30A SP2a or syngo CT VA30A SP3: SOMATOM go.Now (Model #11061610, #11061612, #11061613, #11061618), SOMATOM go.Up (Model #11061620, #11061622, #11061623, #11061628), SOMATOM go.All (Model #11061630, #11061632, #11061638), SOMATOM go.Top (Model #11061640, #11061642, #11061648), SOMATOM go.Sim (Model #11061660, #11061668), SOMATOM go.Open Pro (Model #11061670, #11061678). Update CT018/21/S is a remote update for the following products with software versions syngo.CT VA20A_SP4a or syngo.CT VA20A_SP5: SOMATOM go.Now (Model #11061610, #11061612, #11061613, #11061618), SOMATOM go.Up (Model #11061620, #11061622, #11061623, #11061628), SOMATOM go.All (Model #11061630, #11061632, #11061638), SOMATOM go.Top (Model #11061640, #11061642, #11061648) without dual energy post-processing. Update CT022/21/S is an onsite update for the following product with software versions syngo.CT VA20A_SP4a or syngo.CT VA20A_SP5: SOMATOM go.Top (Model #11061640, #11061642, #11061648) without dual energy post-processing. Update CT025/21/S is an onsite update for the following product with software versions syngo.CT VA30A_SP2, VA30A_SP2a, syngo CT VA30A_SP3, or syngo CT VA30A_FP2 : SOMATOM X.cite (Model #11330001)
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2500-2021
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