Drug recall
91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 &…
FDA recall event 74549 · Class II · Spacelabs Healthcare Inc
Key facts
| Event ID | 74549 |
|---|---|
| Recall numbers | Z-2343-2016 |
| Recalling firm | Spacelabs Healthcare Inc |
| Product type | Devices |
| Products | 91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Option B: ECG/Respiration, Invasive Pressure x2, SpO2, Temperature x2 &… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm has received multiple reports of the Non-Invasive Blood Pressure (NIBP) parameter becoming non-functional with an associated message (No Reading). In addition, there is one of the following… |
| Initiation date | Jul 1, 2016 |
| Report date | Aug 10, 2016 |
| Termination date | May 22, 2017 |
| City | Snoqualmie |
| State | WA |
| Country | United States |
| FEI number | 3010157426 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: