Recall Z-0563-2021— Spacelabs Healthcare, Ltd.
Class II · Terminated
Class II FDA medical device recall by Spacelabs Healthcare, Ltd., initiated 2020-11-06, terminated 2024-10-18. It names one FDA 510(k) clearance: K152881. Product: Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.. Reason: During system upgrade incorrect comments may be added to existing tests. In such instance: Resting ECG and ABP tests which did not contain comments at the time of the upgrade, may have unrelated comments added. Existing comments will not be overwritten or removed. Rhythm ECG Tests may have comments overwritten with unrelated comments. Any tests created after the upgrade are not affected..
- Recalling firm
- Spacelabs Healthcare, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-06
- Terminated
- 2024-10-18
- Firm location
- Hertford, N/A, United Kingdom
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
Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.
Reason for recall
During system upgrade incorrect comments may be added to existing tests. In such instance: Resting ECG and ABP tests which did not contain comments at the time of the upgrade, may have unrelated comments added. Existing comments will not be overwritten or removed. Rhythm ECG Tests may have comments overwritten with unrelated comments. Any tests created after the upgrade are not affected.
Data sourced from openFDA. This site is unofficial and independent of the FDA.