Recall Z-1630-2020— Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Class II · Terminated
Class II FDA medical device recall by Natus Neurology DBA Excel Tech., Ltd. (XLTEK), initiated 2020-03-05, terminated 2021-08-09. It names one FDA 510(k) clearance: K123079. Product: natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph. Reason: The OBM system functional test (impedance and noise) was not carried out on the affected items prior to release to the customer. The manufacturer cannot attest to the system functionality of the affected items..
- Recalling firm
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-03-05
- Terminated
- 2021-08-09
- Firm location
- Oakville, N/A, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
Reason for recall
The OBM system functional test (impedance and noise) was not carried out on the affected items prior to release to the customer. The manufacturer cannot attest to the system functionality of the affected items.
Data sourced from openFDA. This site is unofficial and independent of the FDA.