Recall Z-2689-2016 ยท BSZ Gas-Machine, Anesthesia
Mindray DS USA, Inc. dba Mindray North America
A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. Part numbers 0632F-PA0000X (US domestic) and 0632B-00014 (international)
| Date | Jun 15, 2016 |
| Status | Terminated |
| Reason | Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System. |
| Root cause | Nonconforming Material/Component |
| Action | Mindray sent via certified mail with return receipt a recall letter dated June 15, 2016 to their affected customers. Mindray will replace the gasket on all e-size cylinder yokes on the affected A7 systems. Customer was instructed to contact their local Mindray Service Representative to arrange for this replacement. Customers can continue to use their A7 system while awaiting the replacement of the gasket(s). Customers can contact Ms. Diane Arpino, Director, Quality Operations and Regulatory Affairs via email to: d.arpino@mindray.com or via telephone to: (201)995-8407 |
| Quantity | 167 units (165 units - US) and (2 units - International) |
| Distribution | US Nationwide Distribution to AL, MA, MD, MN, MO, NE, NJ, OK, OR, PA and VA; and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151954 | A7 Anesthesia System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Oct 27, 2015 |