Recall Z-1273-2014— Spacelabs Healthcare, Llc

Name: FDA recall Z-1273-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-14

Class II · Terminated

Class II FDA medical device recall by Spacelabs Healthcare, Llc, initiated 2014-02-14, terminated 2014-05-20. It names one FDA 510(k) clearance: K110779. Product: 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.. Reason: 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..

Recalling firm: Spacelabs Healthcare, Llc
Classification: Class II
Status: Terminated
Initiated: 2014-02-14
Terminated: 2014-05-20
Firm location: Snoqualmie, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K110779 — SPACELABS SMART DISCLOSURE SYSTEMSpacelabs Healthcare·cleared 2011-04-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.