Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 2, 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.
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 ins…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Spacelabs Healthcare, Llc recalled Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Upda… - a moderate-severity action.
Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Upda… was recalled by Spacelabs Healthcare, Llc in April 2, 2014. Reason: Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed on the Clini…. Check the official notice for the remedy. Verify recall #Z-1273-2014 with the FDA Devices before acting.
The recall
Spacelabs Healthcare, Llc issued this moderate-severity FDA Devices recall-Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed on the Clini….
- Moderate
- severity level
- 36 units
- affected scope
- Class II
- classification
- April 2, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1273-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1273-2014) was formally reported on April 2, 2014, with the manufacturer initiating the action on February 14, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Spacelabs Healthcare, Llc is listed as the recalling firm, operating out of Snoqualmie, WA. Federal records list the affected scope as 36 units total: 17 units were distributed in the US and 19 units distributed outside the US..
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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, Czechoslov…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
36 units total: 17 units were distributed in the US and 19 units distributed outside the US.
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1273-2014 |
| Date reported | April 2, 2014 |
| Date initiated | February 14, 2014 |
| Recalling firm | Spacelabs Healthcare, Llc |
| Firm location | Snoqualmie, WA |
| Affected scope | 36 units total: 17 units were distributed in the US and 19 units distributed outside the US. |
| 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, Colombi… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1273-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Spacelabs Healthcare, Llc. Units affected: 36 units total: 17 units were distributed in the US and 19 units distributed outside the US..
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 2, 2014. Severity: Moderate. Recall number: Z-1273-2014.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1273-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 2, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.