Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
FDA device recall Z-0714-2024 · posted 2024-01-11 · Open, Classified
Recall details
- Recalling firm
- Ambu Inc.
- Reason for recall
- Instructions for Use have been updated to add the following warning: Use only M4 screws with the length of 14 16 mm when mounting Ambu aView 2 Advance on a VESA interface. Using longer screw lengths will penetrate the lithium-ion battery and result in a fire hazard and battery leakage which can cause severe burns, smoke inhalation and skin irritation. Using shorter screw lengths could result in unsecure device fastening.
- Action taken
- On December 5, 2023, the firm began notifying their customers via Urgent Field Safety Notice (Correction) letters. Customers were provided with an insert of Instructions for Use to include with their Instructions for Use booklet that highlights the new warning. Should you have additional questions, please contact Sanjay Parikh (sap@ambu.com) or Tammy Feyerherm (tfey@ambu.com).
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- EOQ
- Quantity affected
- 11845 distributed US
- Distribution
- Domestic distribution nationwide.
- Date initiated
- 2023-12-05
- Date posted
- 2024-01-11
- Location
- Columbia, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance (K223299) | Ambu A/S | 2023-06-01 |