The product is Pathfinder SL — Class II medical device recall Z-1831-2012
Terminated recall by Spacelabs Healthcare, Llc, reported 2012-06-27, distributed nationwide. The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter Analyzer reco
| Recall number | Z-1831-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spacelabs Healthcare, Llc, Issaquah, WA, United States |
| Recall initiated | 2012-05-11 |
| Classified | 2012-06-20 |
| Reported by FDA | 2012-06-27 |
| Terminated | 2012-10-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, CH, CY, DE, GB, IL, IS, PL, RO, TH, TR, ZA |
| Quantity | 114 |
| Reason classes | software |
Product
The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and patient monitoring. In addition, incorrect QTc values are reported after moving the cursor. QTc values are timing events between labeled points of interest in the ECG signal that the physician can mark with the cursor. The software is used to edit a family of events and upon conclusion the software crashes with an error message.
Reason for recall
The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter Analyzer records. The software will stop with an error message requiring a restart. In addition, QTc values will not update after moving the marker.
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-1831-2012. 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.