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91496 Ultraview SL Command Module, Options A, B, C, and I recallZ-2343-2016 · Spacelabs Healthcare Inc · initiated Jul 1, 2016

Class II Terminated All recalls posted in August 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Spacelabs Healthcare Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Vendor change control

What the company is doing

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

Recall details

Recall number
Z-2343-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 1, 2016
Posted by the FDA
Aug 4, 2016
Recalling firm
Spacelabs Healthcare Inc
Quantity
3801 modules and 116 PCBAs & valves distributed in the US; 1297 modules and 366 PCBAs & valves distributed outside the US
Product code
DSI
FDA submissions
K103142
Distribution
Worldwide Distribution - USA Distribution and to the countries of : AFGHANISTAN, ARGENTINA, AUSTRALIA, BAHRAIN, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM; CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DOMINICAN REPUBLIC; ECUADOR, EGYPT, ESTONIA, FRANCE, GERMANY, GUATEMALA, HONG KONG, INDIA, IRAN (ISLAMIC REPUBLIC OF), ISRAEL, ITALY, JORDAN, KUWAIT, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, PAKISTAN, PALESTINE, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, Slovakia, SPAIN, SRI LANKA, SWITZERLAND, TAIWAN, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VIET NAM.

Product description

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 & adult/neonate NIBP. Option C: ECG/Respiration, Invasive Pressure x4, SpO2, Cardiac Output, Temperature x2 & adult/neonate NIBP. Option I: SpO2, Temperature x2, & adult/neonate NIBP.

Code information (models, lots, serial numbers)

Manifold Lot Codes: 128280, 129420, 129940, or 155640.

Other devices under the same FDA submission

2 devices cleared under K103142 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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