Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for… recallZ-1273-2014 · Spacelabs Healthcare, Llc · initiated Feb 14, 2014
Class II Terminated All recalls posted in March 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Spacelabs Healthcare, Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling Change Control
What the company is doing
Spacelabs Healthcare began sending out the Medical Device Correction letter, dated 28 February 2014, to domestic customers on 28 February 2014 and to international customers by 7 March 2014. The letter identified the product, the product, the problem, and the action to be taken by the customer. Customers are also directed to call 1-800-522-7025 and select 2 for Technical Support. Customers are advised to dispose the CD, PN: 063-1829-11 Rev A previously supplied and replace it with the replacement CD (Rev B) provided.
Recall details
- Recall number
- Z-1273-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 14, 2014
- Posted by the FDA
- Mar 25, 2014
- Recalling firm
- Spacelabs Healthcare, Llc
- Quantity
- 36 units total: 17 units were distributed in the US and 19 units distributed outside the US.
- Product code
- DQK
- FDA submissions
- K110779
- Distribution
- 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.
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.
Code information (models, lots, serial numbers)
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".
Other devices under the same FDA submission
1 device cleared under K110779 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Intesys® Clinical Suite Smart DisclosureSpacelabs Healthcare (Washington), Inc · COMPUTER, DIAGNOSTIC, PROGRAMMABLE1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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