FDA Device recall Z-1482-2018
Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia machines for use in operat…
- FDA Device
- Class I
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class I recall of Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia machines for use in operat… by Draeger Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1482-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-03-01 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Draeger Medical |
| Distribution | US |
Product
Fabius GS Premium, anesthesia machine, catalog no. 8607000 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 ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).
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.
Identifiers
| code_info | Serial no: ASKF-0224 ASKF-0232 ASKH-0004 ASKH-0007 ASKH-0038 ASKH-0088 ASKH-0132 ASKH-0133 ASKJ-0007 ASKJ-0178…Serial no: ASKF-0224 ASKF-0232 ASKH-0004 ASKH-0007 ASKH-0038 ASKH-0088 ASKH-0132 ASKH-0133 ASKJ-0007 ASKJ-0178 ASKJ-0179 ASKJ-0184 ASKJ-0205 ASKJ-0220 ASKJ-0224 ASKK-0002 ASKK-0006 ASKK-0010 ASKK-0011 ASKK-0014 ASKK-0019 ASKK-0022 ASKK-0023 ASKK-0032 ASKK-0036 ASKK-0038 ASKK-0044 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1482-2018%22
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