Brain Monitor Recall for Incorrect Left-Right Data Labeling
Natus Brain Monitor devices are being recalled due to labeling errors where the left side display shows impedance data for the right side. Two complaints have been received; no injuries reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a labeling error in a medical device with risk-of-harm potential, as incorrect left-right labeling in an EEG device could lead to clinical misinterpretation. However, no injuries or illnesses have been reported. This satisfies the Score 3 criterion: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Natus Neurology is recalling the Natus Brain Monitor Breakout Box (Part Number 021911), a full-montage standard electroencephalograph. The device has a labeling error where the left side display shows impedance data labeled as originating from the right side. Two complaints of this labeling error have been received.
Twenty-seven affected units have been distributed across seven U.S. states: California, Indiana, Missouri, North Carolina, Pennsylvania, Rhode Island, and Texas. The affected devices can be identified by UDI/DI 038283NA00153ED and serial numbers 021918100008-M through 021918100055-M.
No injuries or illnesses related to this issue have been reported. Healthcare facilities with affected devices should contact Natus Neurology for instructions on replacement or repair options.
The recalled product
- Product
- Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
- Manufacturer
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- Hazard
- mis-labeling
- display-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 038283NA00153ED
- Serial Numbers: 021918100008-M
- 021918100014-M
- 021918100015-M
- 021918100017-M
- 021918100019-M
- 021918100020-M
- 021918100021-M
- 021918100025-M
- 021918100026-M
- 021918100028-M
- 021918100032-M
- 021918100034-M
- 021918100036-M
- 021918100038-M
- 021918100039-M
- 021918100040-M
- 021918100041-M
- 021918100044-M
- 021918100046-M
Distribution
Distributed in 7 states:
- CA
- IN
- MO
- NC
- PA
- RI
- TX
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