Mindray cPM Series Patient Monitor Manuals Recalled for Alarm Clarification
Mindray DS USA, Inc. is recalling cPM Series Patient Monitor operator's manuals because descriptions of 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 documentation issues where operator's manuals may contain insufficient descriptions of alarm functions. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Mindray DS USA, Inc. is recalling 1,699 units of the cPM Series Patient Monitor Operator's Manual (cPM 8/cPM 12). The recall involves manuals with part number 046-011732-00, up to and including revision 4.0.
The recall was initiated because certain manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions. The affected manuals were distributed nationwide in the United States and in Canada.
The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled manuals, nor does it report any illnesses, injuries, or deaths associated with the product.
The recalled product
- Product
- cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
- Manufacturer
- Mindray DS USA, Inc.
- Hazard
- Affected units
- 1,699
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. 046-011732-00
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Mindray DS USA, Inc.
See all →- LowCertain Mindray patient monitor manuals need clarification of alarm functions
FDA (Devices) · 2026-10-14
- LowMindray BeneVision Telemetry Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- LowMindray Recalls Passport Series Patient Monitor Operator's Manuals
FDA (Devices) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- LowMindray Panorama and Telemetry Monitoring System Operator's Manuals Recalled
FDA (Devices) · 2026-10-14
Same hazard · documentation error
See all →- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateHenry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging
FDA (Devices) · 2026-09-02
- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- ModeratePower Over Fiber Base Modules Recalled Due to Incorrect Laser Classification and Labeling
FDA (Devices) · 2026-08-05
- ModerateEmbrace shoulder drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01
Similar recalls
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- LowMindray Recalls Passport Series Patient Monitor Operator's Manuals
FDA (Devices) · 2026-10-14
- LowMindray T1 Patient Monitor Operator's Manual Recall for Alarm Descriptions
FDA (Devices) · 2026-10-14
- LowMindray Panorama and Telemetry Monitoring System Operator's Manuals Recalled
FDA (Devices) · 2026-10-14
- LowMindray BeneVision Telemetry Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- LowMindray Recalls BeneView T5 and T8 Operator's Manuals for Alarm Clarification
FDA (Devices) · 2026-10-14