CLASS II Device recall · Reported 18 Mar 2020 · FDA Enforcement Report

DL950 Holter Monitor 1285 Corporate Center Dr recalled

Braemar Manufacturing is recalling DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA, distributed nationwide in the US. The recall was initiated on 22 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll devices manufactured or distributed prior to 01/01/2020 are affected.

Quantity recalled10582

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-1460-2020
FDA event ID: 84883
Recalling firm: Braemar Manufacturing, Eagan, MN
Classification: Class II
Status: Terminated
Recall initiated: 22 Jan 2020
FDA classified: 10 Mar 2020
Reported: 18 Mar 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

22 Jan 2020	Recall initiated by company
10 Mar 2020	Classified by FDA	+48 days
18 Mar 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar confirmed that beginning on January 1, 2020 if a AAA battery is inserted in the recorder and a user attempts to start it, the recorder will display Error: 602 and fail to function for a new patient study. There are no actions that a clinical user can take to clear this error. Even if this error code is displayed, existing ECG recordings stored on the device can still be downloaded via the standard Holter Application Software. Error 602 may be able to be cleared by technical or engineering staff at the customer site.

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

Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only

Where it was distributed

Nationwide. No governmental consignees or Canadian consignees. International distribution to Germany, Spain, Switzerland, France, Finland, Vietnam, Israel, France, Hong Kong, Czech Republic, Finland, Belgium, Sweden, Mexico, Lebanon, United Arab Emirates, Bolivia, Italy, and Belgium.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All devices manufactured or distributed prior to 01/01/2020 are affected.

Where was it sold?

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.

Other products in this recall event

1 other product · FDA event 84883

Reported	Class	Recall	Company	Reason	Where
18 Mar 2020	CLASS II	DL900 Holter Monitor 1285 Corporate Center Dr recalled	Braemar Manufacturing	Device Malfunction	Nationwide

More recalls from Braemar Manufacturing

All 3

Reported	Class	Recall	Company	Reason	Where
1 Jan 2025Device	CLASS I	Monitoring Service Application (MSA) recalled by Braemar Manufacturing	Braemar Manufacturing	Device Malfunction	Nationwide
18 Mar 2020Device	CLASS II	DL900 Holter Monitor 1285 Corporate Center Dr recalled	Braemar Manufacturing	Device Malfunction	Nationwide

Other Patient Monitors recalls

All 1,013

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9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide