Recall Z-0714-2024 · EOQ Bronchoscope (Flexible Or Rigid)
Ambu Inc.
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
| Date | Jan 11, 2024 (initiated Dec 5, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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). |
| Quantity | 11845 distributed US |
| Distribution | Domestic distribution nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223299 | Ambu® aScope 5 Broncho HD 5.0/2.2, Ambu® aScope 5 Broncho HD 5.6/2.8, Ambu® aView 2 Advance Ambu A/S, Jun 1, 2023 |