CLASS I ONGOING Device recall · Reported 1 Jan 2025 · FDA Enforcement Report
Monitoring Service Application (MSA) recalled by Braemar Manufacturing
Braemar Manufacturing is recalling Monitoring Service Application (MSA), distributed nationwide in the US. The recall was initiated on 18 Dec 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0708-2025
- FDA event ID
- 95837
- Recalling firm
- Braemar Manufacturing, San Diego, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 18 Dec 2024
- FDA classified
- 23 Dec 2024
- Reported
- 1 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 18 Dec 2024 | Recall initiated by company | |
| 23 Dec 2024 | Classified by FDA | +5 days |
| 1 Jan 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring service application software.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Where it was distributed
US Nationwide distribution including PR.
Questions about this recall
Why was it recalled?
Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring service application software.
Which lots are affected?
Product Code: N/A UDI code: N/A Software Version - 6.5 to 7.4
Where was it sold?
US Nationwide distribution including PR.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Braemar Manufacturing
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DL900 Holter Monitor 1285 Corporate Center Dr recalled | Braemar Manufacturing | Device Malfunction | Nationwide |
| Device | CLASS II | DL950 Holter Monitor 1285 Corporate Center Dr recalled | Braemar Manufacturing | Device Malfunction | Nationwide |
Other Patient Monitors recalls
All 1,022| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Passport Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | T1 Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | cPM Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | Panorama and Telemetry Monitoring System recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |