Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    204787RF1; 205814RF1; 209826500D; 229P500RF2; 410448RF; 417682BRF; 506857P500; 519663PR500; 519685PR500; 561791RM2; 603668C5; 618635RF; 636625SJR1; 718630PRECISION; 770793KP500D2; 810326P500; 850494WF4; 903731PRP500; 985230DCRF4; and AM16KFZ328.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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, LLC
Reason for Recall:
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.

Product Codes/Lot Numbers:

204787RF1; 205814RF1; 209826500D; 229P500RF2; 410448RF; 417682BRF; 506857P500; 519663PR500; 519685PR500; 561791RM2; 603668C5; 618635RF; 636625SJR1; 718630PRECISION; 770793KP500D2; 810326P500; 850494WF4; 903731PRP500; 985230DCRF4; and AM16KFZ328.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1754-2019

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.

Feb 19, 2025 Infusion Pumps View Details →

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.

Feb 19, 2025 Other Medical Devices View Details →

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.

Feb 19, 2025 Other Medical Devices View Details →