Z-1503-2023Class II

Ultraview SL (UVSL) Command Module, Model 91496

Name: Z-1503-2023 Ultraview SL (UVSL) Command Module, Model 91496
Creator: Spacelabs Healthcare, Inc.
Published: 2023-04-12
License: https://open.fda.gov/license/

GE Healthcare / initiated 2023-04-12 / Open, Classified / root cause: software

FDA source

Spacelabs Healthcare, Inc. began a recall of Ultraview SL (UVSL) Command Module, Model 91496 on 2023-04-12. FDA classified it as Class II and gives the reason as "Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present with no alarms, 2) Newer versions have waveforms absent...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1503-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-12
Posted: 2023-05-03
Recalling firm: GE Healthcare
Product: Ultraview SL (UVSL) Command Module, Model 91496
Product code: DSI Detector And Alarm, Arrhythmia
Reason for recall: Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present with no alarms, 2) Newer versions have waveforms absent with no alarms. This may cause clinicians to miss a potentially catastrophic event.
Root cause tag: software
FDA root cause: Component change control
Action: On 4/12/23 correction notices were sent and customers were provided the following information: In software versions up to and including version 2.03.06: "Processing Suspended" messaging overlays the waveforms, question marks (?) replace the typically found numerical data, and there is an "alarm off" symbol on the far right of the parameter zone while the product in in Suspend status. The patient s ECG and Respiratory waveforms remain displayed in the parameter zone of the user interface while the product is in Suspend status. In software version 2.04 and later, "Processing Suspended" messaging overlays the waveform zone, question marks (?) replace the typically found numerical data, and there is an "alarm off" symbol on the far right of the parameter zone while the product in in suspend status; however, the active patient waveforms are no longer displayed. We believe that the halted display of parameter waveforms more clearly communicate that the product is in Suspend status. The recalling firm recommends: 1) All users must be adequately trained on all versions of the product that will be used. 2) Ensure that all users are aware that Suspend Processing status means that all parameter processing and alarms are stopped and will not function. 2) The Suspended state must be manually re-engaged by pressing the "Resume Processing" button to return to active processing and return the alarms to the intended operation. 3) Please pass this notice on to those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. 4) All customers should acknowledge receipt and understanding of the notice at the following URL: https://spacelabshealthcare.com/support/recall-reply-form/2023-00001-c/ Questions regarding this correction can be directed to Technical Support at 1-800-522-7025, select option 2.
Quantity in commerce: 1,088
Distribution: US Nationwide distribution in the states of SD, KY, MO, WA, OH, NC, CA, OR, TX, GA, IL, OK, SC, PA, AL, KS, FL, ID, MI, MN, IA, NJ, MD, VA, AR, CT, NE, LA, AK, MS, ME, WV, NY, AZ, TN, WY, IN, MA, MT, CO, DE, ND, WI, NV, RI, NH, UT.
Product codes and lots: Software version 2.03.06 and earlier and software version 2.04 and later.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1503-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1503-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-10	2023-05-03

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)