Class II — Spacelabs Healthcare Inc
| Recalling firm | SPACELABS HEALTHCARE, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms. |
| Product | Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from a patient in a clinical environment. |
| Quantity | 64 devices |
| Distribution | US Distribution to GA. |
| Initiated | 2014-05-08 |
| Classified | 2014-06-03 |
| Terminated | 2014-06-03 |
| Recall number | Z-1705-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Spacelabs Healthcare Inc (Z-1705-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68357/
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