Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN:… — Class II medical device recall Z-1273-2014
Terminated recall by Spacelabs Healthcare, Llc, reported 2014-04-02, distributed nationwide. Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed on the Clinic
| Recall number | Z-1273-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spacelabs Healthcare, Llc, Snoqualmie, WA, United States |
| Recall initiated | 2014-02-14 |
| Classified | 2014-03-25 |
| Reported by FDA | 2014-04-02 |
| Terminated | 2014-05-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, CO, CZ, FR, GB, IT, NL, PL, SA, TR |
| Reason classes | software |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1273-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.