🔍 RecallPedia

GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and transport patient care episodes.

Class I - Dangerous
🏥 Medical Devices Recalled: February 17, 2012 GE Healthcare Diagnostic Equipment Nationwide

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  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:
GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care.
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 Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and transport patient care episodes.

Product Codes/Lot Numbers:

Parent SN SA310310978GA SA310454946GA SA310475517GA SA310475525GA SA310475536GA SA310475537GA SA310475540GA SA310475566GA SA310475575GA SA310475581GA SA310475582GA SA310475585GA SA310475591GA SA310475598GA SA310475600GA SA310475608GA SA310475609GA SA310475610GA SA310475611GA SA310028114GR SA310028140GR SA310028149GR SA310149355GR SA310259884GA SA310259951GR SA310260040GA SA310260303GR SA310260308GR SA310260320GA SA310260359GR SA310260383GA SA310260402GA SA310260553GA SA310290668GA SA310310883GA SA310310926GA SA310310993GA SA310321001GA SA310341381GA SA310351501GA SA310361698GA SA310361707GA SA310361785GA SA310361945GA SA310372076GA SA310372167GR SA310372294GA SA310382325GR SA310382326GR SA310382347GR SA310382364GA SA310382635GA SA310382657GA SA310382754GA SA310382814GA SA310382838GA SA310382839GA SA310382849GA SA310392898GA SA310392937GR SA310393202GA SA310393246GA SA310393263GR SA310403312GA SA310403374GA SA310413458GA SA310413473GA SA310413495GA SA310413534GA SA310413537GA 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Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0524-2013

Related Recalls

GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867-045.

GE Healthcare

Class I - Dangerous

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.

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GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-014; 8) 2038437-0XX; 9) 2098071-004; 10) 2109571-002; 11) 2109571-006; 12) 2109571-010; 13) 2109594-009; 14) 2109594-011; 15) K2090PS; 16) K2090PTED; 17) MANLEGACY114; 18) MANLEGACY64.

GE Healthcare

Class I - Dangerous

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 →

GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015; 6) 2049588-012 ; 7) 2052829-001.

GE Healthcare

Class I - Dangerous

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 →