FDA Medical Device Recalls (openFDA)
Mindray DS USA, Inc., dba Datascope Patient Monitoring: AS3000 Anesthesia Delivery System. Datascope Patient Monitoring; A Mindray Global Company. The AS3000 is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
- Recall number
- Z-0319-2009
- Recalling firm
- Mindray DS USA, Inc., dba Datascope Patient Monitoring
- Product
- AS3000 Anesthesia Delivery System. Datascope Patient Monitoring; A Mindray Global Company. The AS3000 is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
- Status
- Terminated
- Initiated
- 2008-10-07
- Posted
- 2008-12-05
- Terminated
- 2008-12-08
- Reason
- Two issues have been identified with the AS3000 unit. 1. The threadlocker of the caster (wheels) may not have been utilized, which may allow the caster to loosen and possibly separate from the unit. 2. The use of select brands of pre-pack absorber in the absorber canister of the AS3000 has been associated, in some cases, with gas leakage around the pre-pack, rather than through the absorber mate
- Root cause
- Component design/selection
- Action
- Notification (Urgent Product Field Correction) letters were sent to the one consignee on October 7, 2008 by Federal Express overnight delivery.
- Quantity
- 2 units
- Distribution
- Only 2 units are in distribution, both in the same facility in Redondo Beach, CA.
- Lot, serial or model codes
- Serial Number: AN0804-001 and AN0804-006. Each AS3000 Anethesia Delivery System is labeled with a unique serial number.
- 510(k) numbers
- ["K080175"]
- PMA numbers
- not on file
- Product code
- BSZ
- Firm FEI
- 2221819
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28