Device recall: ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
Class III FDA enforcement event 99828. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Mindray DS USA, Inc. started this device recall on 31 Aug 2026. The firm address in the FDA record is in Mahwah, NJ. FDA put the recall in Class III. FDA event 99828 has 8 product records. The first FDA enforcement report date is 14 Oct 2026. The record gives the status Ongoing. 48 of the 677 device events that started in 2026 have more product records. The median device event of 2026 has 1 product record.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide - Nationwide and the country of Canada.
Recalling firm
Mindray DS USA, Inc., Mahwah, NJ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
8 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0109-2027 | ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A | 32,184 units | Class III | Ongoing | 14 Oct 2026 |
| Z-0110-2027 | BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22. | 44,651 units | Class III | Ongoing | 14 Oct 2026 |
| Z-0111-2027 | BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80 | 29,737 units | Class III | Ongoing | 14 Oct 2026 |
| Z-0112-2027 | Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60). | 11,831 units | Class III | Ongoing | 14 Oct 2026 |
| Z-0113-2027 | BeneView Series. Operator's Manuals: T5 / T8 | 133 units | Class III | Ongoing | 14 Oct 2026 |
| Z-0114-2027 | Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V | 39,891 units | Class III | Ongoing | 14 Oct 2026 |
| Z-0115-2027 | cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12 | 1,699 units | Class III | Ongoing | 14 Oct 2026 |
| Z-0116-2027 | T1 Patient Monitor. Operator's Manual: T1 Patient Monitor | 4,946 units | Class III | Ongoing | 14 Oct 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Device events that started in 2026
- 677
- Share of these events in Class III
- 1%
- Product records in this event
- 8
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-0109-2027The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 99828. https://recallregister.com/fda/iii/99828/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 27 Oct 2026
- Newest FDA report date on the register
- 21 Oct 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide - Nationwide and the country of Canada.
- What quantity of product is in FDA event 99828?
- The event has 8 product records. The first record gives this quantity:
32,184 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2026 have the same class?
- 1% of the 677 device events that started in 2026 are in Class III.