The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is
FDA device recall Z-2083-2015 · posted 2015-07-15 · Terminated
Recall details
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Reason for recall
- Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and Suction Modules, the suctioning function cannot be activated or controlled by the suction unit on/off switch leading to a decrease or loss of suctioning capability of the modules.
- Action taken
- Maquet sent an Urgent Medical Device Field Action Removal and Replacement Form/Device Removal Response Form dated March 2, 2015 to their affected customers via FedEx. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed read through the letter and inform all members of their staff who may use the affected device. Fill out the attached Device Removal Response Form with requested information, sign and date and fax/email the Response Form using the fax/email information provided. Customers with questions were instructed to contact their Maquet Service Representative or Maquet Technical Support at 1-888-627-8383 (press option 3, followed by option 1 and then optionn 1 again.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 104 units
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, China, Colombia, Croatia, Czech Republic, Ecuador, Finland, France, Germany, Hong Kong, India, Israel, Japan
- Date initiated
- 2015-03-02
- Date posted
- 2015-07-15
- Date terminated
- 2016-04-29
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 (K133958) | Maquet Critical Care AB | 2014-03-20 |