Recall Z-1481-2018 ยท BSZ Gas-Machine, Anesthesia
Draeger Medical, Inc.
Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventil
| Date | May 8, 2018 (initiated Mar 1, 2018) |
| Status | Terminated |
| Reason | The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail. |
| Root cause | Process control |
| Action | On March 1, 2018, the recalling firm notified affected customers via an Urgent Medical Device Recall letter. The recalling firm stated that customers would receive replacement motors for potentially affected devices. Until the replacement occurred, customers were instructed to continue to operate their devices with the usual attention and make sure that a manual resuscitator for emergency ventilation is kept ready according to the instructions for use. Customers were also supplied with a reply card to indicate that they had received the notification. Customers with questions about the letter |
| Quantity | 8 |
| Distribution | US Nationwide Distribution to accounts in 21 states: AZ, CA, CO, ID, IL, KS, MA, MI, MS, NC, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI; and PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072884 | FABIUS MRI Draeger Medical AG & Co. KG, Jul 30, 2008 |