Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.

FDA device recall Z-0809-2025 · posted 2025-01-07 · Open, Classified

Recall details

Recalling firm

Spacelabs Healthcare, Inc.

Reason for recall

Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts; necessary clinical intervention could be delayed.

Action taken

On 11/25/2024, correction notices were sent to customers asking them to do the following: 1) Service manual has been updated by adding a section for "Required periodic system maintenance of Spacelabs Telemetry Farm", pages 5-30 through 5-35. 2) Download current versions of the Service Manual and PM Instructions at https://manuals.spacelabshealthcare.com/ 3) You may also obtain a copy of the latest manual by contacting the firm's Technical Support. 4) Discard previous copies of these documents 5) Complete the online customer acknowledgement form which can be accessed by using URL: https://spacelabshealthcare.com/support/recall-reply-form/recall-reply-form-xtr-windows-web-proxy-issue/ For additional information or to report any adverse events as a result of this issue, please contact the firm's Technical Support 1-800-522-7025 and select 2 for Technical Support

Root cause

Labeling design

Status

Open, Classified

Product code

MHX

Quantity affected

2265

Distribution

US: OK, MN, IA, SC, NE, MI, NY, KY, GA, MO, MT, LA, WA, SD, CO, PA, WY, TX, ID, NJ, FL, OH, MS, OR, AK, IL, AR, KS, AL, TN, WI, VA, NM, CA, IN, RI, NV, MA, NC, ME, CT, AZ, MD, PR. OUS: Kuwait, Austral

Date initiated

2024-11-25

Date posted

2025-01-07

Location

Snoqualmie, WA

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