Z-0115-2027

cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12

Name: Z-0115-2027 cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
Creator: Mindray DS USA, Inc.
Published: 2026-08-31
License: https://open.fda.gov/license/

Mindray DS USA, Inc. / initiated 2026-08-31 / Open, Classified

FDA source

Recall record

Recall number: Z-0115-2027
Status: Open, Classified
Initiated: 2026-08-31
Posted: 2026-10-07
Recalling firm: Mindray DS USA, Inc.
Product: cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
FDA root cause: Labeling design
Action: Mindray notified consignees on about 08/31/2026 via "URGENT: Medical Device Recall" letter. Consignees were informed that Mindray was providing updated instructions regarding physiological alarms in certain Mindray patient monitoring device Instructions for Use (IFU)/Operator s Manuals. This action is limited to updates to the IFU/Operators Manual content and does not require removal, return, repair, or replacement of the monitors. Consignees were instructed to continue using the Mindray monitors associated with the affected operator s manual, ensure that applicable clinical staff are made aware of the content of this letter and the Operator s Manual Addendum, and if monitors have been distributed or transferred to another organization, please forward this notice to that organization. Additionally, consignees were instructed to complete and return the Acknowledgment and Receipt Form provided. Distributors were instructed to notify their customers. Mindray provided the QR Code for the Operator s Manual Addendum - Addendum of the Arrhythmia Analysis Statement on their portal.
Quantity in commerce: 1,699 units
Distribution: Worldwide - Nationwide and the country of Canada.
Product codes and lots: Part Numbers of the cPM Series Patient Monitor Operator's Manual: 1. cPM 12/cPM 8 Operator's Manual up to and including revision 4.0; Part No. 046-011732-00

Product code MHX

K153448Class IIPassport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. / cleared 2016-03-03

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-09. View this recall on fda.gov (opens on fda.gov)