Recall Z-0714-2024— Ambu Inc.

Name: FDA recall Z-0714-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-05

Class II · Ongoing

Class II FDA medical device recall by Ambu Inc., initiated 2023-12-05. It names one FDA 510(k) clearance: K223299. Product: Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2. 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..

Recalling firm: Ambu Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-12-05
Firm location: Columbia, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K223299 — Ambu® aScope 5 Broncho HD 5.0/2.2, Ambu® aScope 5 Broncho HD 5.6/2.8, Ambu® aView 2 AdvanceAmbu A/S·cleared 2023-06-01

K-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

Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.