SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 106527 106565 106456 106464 106545 106237 106375 106526 106484 106562 106400 106260 106459 106150 106593 106133 106115 106360
- 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:
- The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies.
Product Codes/Lot Numbers:
106527 106565 106456 106464 106545 106237 106375 106526 106484 106562 106400 106260 106459 106150 106593 106133 106115 106360
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1920-2019
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