Z-2343-2016Class II

91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 &...

Name: Z-2343-2016 91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 &...
Creator: Spacelabs Healthcare Inc
Published: 2016-07-01
License: https://open.fda.gov/license/

GE Healthcare / initiated 2016-07-01 / Terminated / root cause: supplier

FDA source

Spacelabs Healthcare Inc began a recall of 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... on 2016-07-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2343-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-01
Posted: 2016-08-04
Terminated: 2017-05-22
Recalling firm: GE Healthcare
Product: 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.
Product code: DSI Detector And Alarm, Arrhythmia
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.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: 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
Quantity in commerce: 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, 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 codes and lots: Manifold Lot Codes: 128280, 129420, 129940, or 155640.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2343-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2343-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-04

Product code DSI

K103142Class IISpacelabs Multi-Parameter ModuleSpacelabs Healthcare, Inc. / cleared 2011-03-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)