Home / Recalls / GE Healthcare It / Z-0337-2014

Z-0337-2014 Class II Terminated

Recalled by GE Healthcare It — Barrington, IL

FDA device recall Z-0337-2014 was initiated by GE Healthcare It on March 11, 2013 and is designated Class II. Reason for recall: 1) Under rare network conditions, a Centricity Perinatal process may maintain an incorrect count of Patient slots in use which may lead to an inability to access the patient roster. The user is tempor… The recall status is terminated (terminated June 10, 2016). Affected quantity: 1,132 units.

Recall Details

Product Type
Devices
Report Date
November 27, 2013
Initiation Date
March 11, 2013
Termination Date
June 10, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,132 units

Product Description

Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also be used in physicians offices and outpatient clinics. This product is primarily intended to serve the purpose of electronic documentation of clinical data and is designed to accept, transfer, display, calculate, store and manage clinical data. System capabilities provide the user with the ability to acquire data from the medical devices and to document, annotate, display, store, print, export and retrieve patient clinical practice information. This product is intended for professional use only.

Reason for Recall

1) Under rare network conditions, a Centricity Perinatal process may maintain an incorrect count of Patient slots in use which may lead to an inability to access the patient roster. The user is temporarily unable to review or edit form and chart information. This could result in a potential delay of care; however active fetal strips and permanent patient data storage are not affected. 2) When

Distribution Pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Australia, Canada, Denmark, Germany, Hong Kong, Korea, South Korea, Thailand and United Kingdom.

Code Information

Centricity Perinatal and Centricity Intensive Care Versions: 6.60, 6.60.9, 6.70.0, 6.70.1, 6.70.5, 6.70.6, 6.80.0, 6.80.1, 6.90.0, 6.90.1, 6.91.1

Other recalls by GE Healthcare It

  • Z-0748-2014 Class II — Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation (August 26, 2013)
  • Z-0116-2014 Class II — The Centricity PACS Workstation is intended for use as a primary diagnostic and (June 11, 2013)
  • Z-0833-2015 Class II — Centricity Enterprise Archive is a software product for receiving, archiving and (April 19, 2013)
  • Z-0620-2014 Class II — The Centricity Laboratory System is intended to be an information system designe (March 12, 2013)
  • Z-0330-2014 Class II — The Centricity Laboratory System is intended to be an information system designe (March 12, 2013)
  • Z-2300-2016 Class II — Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 (February 18, 2013)
  • Z-0865-2014 Class III — The Centricity Laboratory System is intended to be an information system designe (November 20, 2012)
  • Z-1585-2013 Class II — The Centricity Laboratory System is intended to be an information system designe (November 20, 2012)
  • Z-2671-2016 Class II — Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is (November 20, 2012)
  • Z-2739-2016 Class II — Centricity Enterprise Archive is a software product for receiving, archiving and (November 16, 2012)

FDA data resources