Food, drugs, devices › Spacelabs Healthcare, Llc
Device recall: Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are ge
FDA enforcement event 63007 is a device recall by Spacelabs Healthcare, Llc of Issaquah, WA, initiated 27 Aug 2012 and classified Class II, with 1 product record.
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. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 15 Apr 2013. Initiation: voluntary: firm initiated. Spacelabs Healthcare, Llc has 10 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, Llc, Issaquah, WA.
Reason for recall
"There is a potential failure of the Integrated Module Housing causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing."
Distribution
"Worldwide Distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2382-2012 | Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm… | 527 units total; 350 US and 177 International | Class II | Terminated | 26 Sep 2012 |
Context
Other enforcement events for Spacelabs Healthcare, Llc
All 10 events for Spacelabs Healthcare, Llc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "There is a potential failure of the Integrated Module Housing causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing."
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: "Worldwide Distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Apr 2013. "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.