Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1273-2014 — Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ICS G2 Clinical Access software onto hospital personal computers.

U.S. FDA — Device Enforcement · United States · 2014-02-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1273-2014
Date of alert
2014-02-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Spacelabs Healthcare, Llc
Product category
device
Product type
Devices
Reported risk: Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed on the Clinical Access CD are incorrect and it will prevent the customer from installing Clinical Access.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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