Food, drugs, devices › Spacelabs Healthcare Inc
Device recall: Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is
Spacelabs Healthcare Inc (Snoqualmie, WA) initiated this device recall on 8 May 2014; FDA lists 1 product record under event 68357, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 3 Jun 2014. Initiation: voluntary: firm initiated. Spacelabs Healthcare Inc has 27 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Spacelabs Healthcare Inc, Snoqualmie, WA.
Reason for recall
"A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms."
Distribution
"US Distribution to GA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1705-2014 | 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. | 64 devices | Class II | Terminated | 11 Jun 2014 |
Context
Other enforcement events for Spacelabs Healthcare Inc
All 27 events for Spacelabs Healthcare Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution to GA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 Jun 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.