02
Apr
2014

Spacelabs Healthcare G2 Clinical Access Cl II

0

Company Spacelabs Healthcare, Llc.
Date of Enforcement Report:4/2/2014
Class lI:

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. Recall Number Z-1273-201

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/MANUFACTURER
Spacelabs Healthcare, Llc., Snoqualmie WA on.2/14/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
36 units total: 17 units were distributed in the US and 19 units distributed outside the US

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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