Device recall

Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).

FDA recall source

Recall number

Z-0112-2027

Event id

99828

Status

Ongoing

FDA classification

Class III

Recalling firm

Mindray DS USA, Inc.

Report date

Oct 14, 2026

Posted

Oct 7, 2026

Initiated

Aug 31, 2026

Center classification date

Oct 7, 2026

Product code

MSX

Device type

System, Network And Communication, Physiological Monitors

Reason

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Root cause

Labeling design

Quantity

11,831 units

Code info

Part Numbers of the Panorama and Telemetry Monitoring System Operator's Manuals: 1. Panorama Telepack-608 Telemetry Monitoring System Operator's Manual up to and including revision 1.0; Part No. 046-007526-00 2. TMS-6016 Operator's Manual up to and including revision 11.0; Part No. 046-005012-00

Distribution

Worldwide - Nationwide and the country of Canada.

Voluntary or mandated

Voluntary: Firm initiated

Related 510(k)s

K242728

Location

Mahwah, NJ, United States