The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0337-2014·Announced 2013-11-27

GE Healthcare Recalls Centricity Perinatal and Intensive Care Software

GE Healthcare is recalling Centricity Perinatal and Intensive Care software due to a rare network issue that may temporarily prevent users from accessing patient rosters.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential delay of care due to temporary inability to access patient rosters, but active fetal strips and permanent data storage are not affected, and no injuries or illnesses are reported.

Plain-English summary

GE Healthcare is recalling 1,132 units of Centricity Perinatal and Centricity Intensive Care software. The software is intended for use in clinical departments such as Labor and Delivery, Postpartum Maternal Care, newborn Nursery, and critical care units including Neonatal Intensive Care Units (NICU). The affected versions are 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, and 6.91.1.

The recall is due to a rare network condition that may cause the Centricity Perinatal process to maintain an incorrect count of Patient slots in use. This error may lead to an inability to access the patient roster, temporarily preventing users from reviewing or editing form and chart information. This could result in a potential delay of care, although active fetal strips and permanent patient data storage are not affected.

The affected software was distributed worldwide, including the United States (nationwide), Puerto Rico, Australia, Canada, Denmark, Germany, Hong Kong, Korea, South Korea, Thailand, and the United Kingdom. Users should contact GE Healthcare for instructions on how to resolve the issue.

The recalled product

Product
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…
Manufacturer
GE Healthcare It
Category
Medical Device — Clinical Software
Hazard
Affected units
1,132

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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