CLASS II Device recall · Reported 2 Apr 2014 · FDA Enforcement Report

G2 Clinical Access Mislabeled CDs for PN recalled

Spacelabs Healthcare is recalling G2 Clinical Access Mislabeled CDs for PN: 063-1829-11, distributed nationwide in the US. The recall was initiated on 14 Feb 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesTwo G2 Clinical Access CD part numbers are affected: PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Serial numbers distributed in the US: "040-1565-10" and "063-1829-11". Serial number distributed outside the US: "063-1829-11".

Quantity recalled36 units total: 17 units were distributed in the US and 19 units distributed outside the US.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1273-2014
FDA event ID: 67638
Recalling firm: Spacelabs Healthcare, Snoqualmie, WA
Classification: Class II
Status: Terminated
Recall initiated: 14 Feb 2014
FDA classified: 25 Mar 2014
Reported: 2 Apr 2014
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Medical Software

Timeline

14 Feb 2014	Recall initiated by company
25 Mar 2014	Classified by FDA	+39 days
2 Apr 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution- USA (nationwide) including the states of Alabama, Florida, Georgia, Louisiana, Missouri, New York, South Carolina, Tennessee, Texas and Wyoming, and the countries of Australia, Canada, Czechoslovakia, China, Colombia, France, Great Britain, Italy, Netherlands, Poland, Saudi Arabia, and Turkey.

Nationwide Alabama Florida Georgia Louisiana Missouri New York South Carolina Tennessee Texas Wyoming

Questions about this recall

Why was it recalled?

Which lots are affected?

Two G2 Clinical Access CD part numbers are affected: PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Serial numbers distributed in the US: "040-1565-10" and "063-1829-11". Serial number distributed outside the US: "063-1829-11".

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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