Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Us...
FDA Device Recall #Z-1542-2015 — Class II — April 17, 2015
Recall Summary
| Recall Number | Z-1542-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 17, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Spacelabs Healthcare Inc |
| Location | Snoqualmie, WA |
| Product Type | Devices |
| Quantity | 1999 units total (1932 in the US and 67 international) |
Product Description
Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.
Reason for Recall
Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was affected. Customer reported that during the time that the module is resetting (~10 seconds), monitoring of all parameters will be suspended. Upon completion of this sequence, alarms will be reset to their default values.
Distribution Pattern
Worldwide Distribution- US Nationwide in the states of AL, DE, GA, ID, IL, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, VA, WA and the country of France.
Lot / Code Information
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1496-121984, 1496-121985, 1496-121986, 1496-121987, 1496-121988, 1496-121989, 1496-121990, 1496-121991, and 1496-121992. **********SERIAL NUMBERS INTERNATIONAL********************************* 1496-001139, 1496-001925, 1496-002364, 1496-002372, 1496-002410, 1496-002411, 1496-002483, 1496-002486, 1496-002501, 1496-002509, 1496-002521, 1496-002542, 1496-002543, 1496-003059, 1496-006322, 1496-006323, 1496-006324, 1496-006702, 1496-009407, 1496-009518, 1496-009550, 1496-009739, 1496-009953, 1496-009979, 1496-010250, 1496-010251, 1496-010257, 1496-010259, 1496-010261, 1496-010779, 1496-011011, 1496-011322, 1496-011553, 1496-011927, 1496-012393, 1496-012715, 1496-012729, 1496-014969, 1496-016724, 1496-017329, 1496-019070, 1496-033510, 1496-038108, 1496-113895, 1496-113896, 1496-113911, 1496-113935, 1496-113936, 1496-113938, 1496-113939, 1496-113940, 1496-113941, 1496-113944, 1496-113945, 1496-113946, 1496-113947, 1496-113948, 1496-113949, 1496-113950, 1496-113951, 1496-113952, 1496-113953, 1496-113954, 1496-113956, 1496-113957, 1496-113958, and 1496-113959.
Other Recalls from Spacelabs Healthcare Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0532-2018 | Class II | Spacelabs Healthcare Xhibit Telemetry Receiver,... | Jan 17, 2018 |
| Z-0332-2017 | Class II | Xhibit Central Station, Model 96102. Inten... | Oct 18, 2016 |
| Z-2886-2016 | Class II | Spacelabs Healthcare Xhibit Telemetry Receiver ... | Aug 25, 2016 |
| Z-2885-2016 | Class II | Spacelabs Healthcare Xhibit Central Station, Mo... | Aug 25, 2016 |
| Z-2343-2016 | Class II | 91496 Ultraview SL Command Module, Options A, B... | Jul 1, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.