91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neona
FDA device recall Z-2343-2016 · posted 2016-08-04 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare Inc
- 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 three error messages: Inflate Error, HW Error, or No Data.
- Action taken
- Spacelabs expanded the recall and sent an Urgent - Medical Device Correction letter dated August 30, 2016, to additional affected customers via priority mail (return receipt requested). On September 6, 2016, a customer letter (translated as necessary) was sent via email to all international subsidiaries and distributors of record. ********************************************************************************************** Spacelabs Healthcare Inc, sent an Urgent - Medical Device Correction letter dated July 1, 2016, to all affected customers (return receipt requested). On July 8, 2016, a customer letter (translated as necessary) was sent via email to all international subsidiaries and distributors of record. Spacelabs Healthcare will contact customers to schedule a convenient time for a Spacelabs service technician to update their affected Command Module(s) at no cost. For additional information or technical assistance, please contact: Technical Support 1-800-522-7025 and select (2) for Technical Support
- Root cause
- Vendor change control
- Status
- Terminated
- Product code
- DSI
- Quantity affected
- 3801 modules and 116 PCBAs & valves distributed in the US; 1297 modules and 366 PCBAs & valves distributed outside the US
- Distribution
- Worldwide Distribution - USA Distribution and to the countries of : AFGHANISTAN, ARGENTINA, AUSTRALIA, BAHRAIN, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM; CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COST
- Date initiated
- 2016-07-01
- Date posted
- 2016-08-04
- Date terminated
- 2017-05-22
- Location
- Snoqualmie, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS MULTI-PARAMETER MODULE (K103142) | Spacelabs Healthcare, Inc. | 2011-03-03 |