Natus brain monitor breakout box shows right side impedance under left
The Natus Brain Monitor Breakout Box is being recalled after two complaints that the left side labeling showed impedance for the right side. 27 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Risk-of-harm product: left and right channel information may be displayed under the wrong side on a brain monitoring device, with no patient harm reported.
Plain-English summary
The Natus Brain Monitor Breakout Box, part number 021911, a full-montage standard electroencephalograph component, UDI/DI 038283NA00153ED, is being recalled. The action covers 27 units, identified by the serial numbers in the recall notice.
The stated reason is that Natus received two complaints of left side labeling showing impedance for the right side. The FDA classified the action as Class II. The source does not report any patient harm having occurred.
Distribution was in California, Indiana, Missouri, North Carolina, Pennsylvania, Rhode Island and Texas. The devices are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected units using the part number, UDI/DI and serial numbers above and follow the instructions issued by Natus.
The recalled product
- Product
- Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
- Manufacturer
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- Category
- Medical Device — EEG component
- Affected units
- 27
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
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