Mindray Panorama and Telemetry Monitoring System Operator's Manuals Recalled
Mindray DS USA, Inc. is recalling Panorama and Telemetry Monitoring System operator's manuals because descriptions of selected physiological alarm functions may be insufficient or require clarification.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall involves operator's manuals with descriptions that may be insufficient or require clarification regarding alarm functions. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Mindray DS USA, Inc. is recalling 11,831 units of Panorama and Telemetry Monitoring System operator's manuals. The affected manuals include the Panorama Telepack-608 Telemetry Monitoring System Operator's Manual up to and including revision 1.0 (Part No. 046-007526-00) and the TMS-6016 Operator's Manual up to and including revision 11.0 (Part No. 046-005012-00). These manuals were distributed nationwide and in Canada.
The recall was initiated because certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Consumers and healthcare facilities should check their inventory for the specific part numbers and revisions listed above. Mindray DS USA, Inc. is the recalling firm responsible for this action.
The recalled product
- Product
- Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).
- Manufacturer
- Mindray DS USA, Inc.
- Hazard
- Affected units
- 11,831
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part No. 046-005012-00
Distribution
Distributed nationwide across the United States.
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