GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Legacy and Legacy D Table is intended for use in a diagnostic X-ray system to support patient during general purpose radiological procedures in the horizontal, vertical and Trendelenburg positions.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Mfg Lot or Serial # Model, Catalogue or Code # 00000959002WK7 2258627 00000966338WK6 2258627 00000966611WK6 2258627 00000956387WK5 2258627 00000968741WK9 2258627 00000961510WK5 2258627 00000972529WK2 2258627 00000962527WK8 2258627 00000963526WK9 2258627 00000955594WK7 2258627 00000956587WK0 2258627 00000959354WK2 2258627 00000964963WK3 2258627 00000955822WK2 2258627 00000969028WK0 2258627 00000970010WK5 2258627 00000977743WK4 2258627 00000977741WK8 2258627 00000961823WK2 2258627 00000966949WK0 2258627 00000974520WK9 2258627 00000969300WK3 2258627 00000980632WK4 2258627 00000968416WK8 2258627 00000954452WK9 2258627 00000976569WK4 2258627 00000966357WK6 2258627 00000965746WK1 2258627 00000973833WK7 2258627 00000968411WK9 2258627 00000981014WK4 2258627 00000978814WK2 2258627 00000983374WK0 2258627 00000969352WK4 2258627 00000956745WK4 2258627 00000959683WK4 2258627 00000960138WK6 2258627 00000978807WK6 2258627 00000966622WK3 2258627 00000972384WK2 2258627 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- 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:
- GE Healthcare
- Reason for Recall:
- The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range of travel is 1.1 in (28mm) from the lowest point of normal SFD/IDD vertical compression. A fall of the SFD/IDD could result in an injury to a patient or operator.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Legacy and Legacy D Table is intended for use in a diagnostic X-ray system to support patient during general purpose radiological procedures in the horizontal, vertical and Trendelenburg positions.
Product Codes/Lot Numbers:
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Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1966-2015
Related Recalls
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.