FDA Medical Device Recalls (openFDA)
Mindray DS USA, Inc., dba Datascope Patient Monitoring: Datascope AS3000 Anesthesia System; Mindray, North America. The AS3000 Anesthesia Delivery System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas. The AS3000 is intended for use in operating rooms. It is used with O2, N2O and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine.
- Recall number
- Z-1313-2010
- Recalling firm
- Mindray DS USA, Inc., dba Datascope Patient Monitoring
- Product
- Datascope AS3000 Anesthesia System; Mindray, North America. The AS3000 Anesthesia Delivery System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas. The AS3000 is intended for use in operating rooms. It is used with O2, N2O and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine.
- Status
- Terminated
- Initiated
- 2010-03-05
- Posted
- 2010-04-08
- Terminated
- 2012-04-25
- Reason
- An issue affecting the caster mount on the AS3000 System have been identified, specifically reports of the caster mount breaking, causing the wheel to fall off and the unit to tip.
- Root cause
- Other
- Action
- An "URGENT PRODUCT FIELD CORRECTIVE ACTION" letter dated March 5, 2010 was sent certified mail to all facilities/customers that have the AS3000 units. The letter described the product, problem and corrective Action/remediation by the firm. A Mindray Service Representative will contact the customers to arrange for the caster mounts to be replaced on the AS3000 units in their facilities at no cost. If you have any questions, please contact Karen Maine of the Mindray DS USA, Inc. Marketing Department at 201-995-8612 or k.maine@mindray.com.
- Quantity
- 372 units in US, 107 internationally.
- Distribution
- Worldwide Distribution: USA and Mexico, Columbia, Turks & Caicos Islands, BWI; Ecuador, Bolivia, Peru, Dominican Republic, Netherlands Antilles, Chile.SA
- Lot, serial or model codes
- Product numbers 0998-00-3024-01.
- 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