DL900 Series Holter Recorder

• 2 recalls, same reason

  • Terminated Z-1460-2020 FDA Class II ·initiated 22 Jan 2020
  • Terminated Z-1459-2020 FDA Class II ·initiated 22 Jan 2020

  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.

• • Terminated Z-1345-2020 FDA Class II ·initiated 13 Jan 2020

  if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserted in the docking station, the recorder will display Error: 602 and fail to function for a new patient study.

510(k) Number

K071733 ↗

FDA Product Code

MWJ

Device Class

Class II

Regulation

21 CFR Part 870.2800

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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