FDA Medical Device Recalls (openFDA)
Impact Instrumentation, Inc.: Model 754/754M Disposable MRI Ventilator Circuit Impact Instrumentation Inc., 23 Fairfield Place, West Caldwell, NJ 07006. Accessory for 700 Series 754/754m Ventilators during MRI examinations
- Recall number
- Z-3080-2011
- Recalling firm
- Impact Instrumentation, Inc.
- Product
- Model 754/754M Disposable MRI Ventilator Circuit Impact Instrumentation Inc., 23 Fairfield Place, West Caldwell, NJ 07006. Accessory for 700 Series 754/754m Ventilators during MRI examinations
- Status
- Terminated
- Initiated
- 2011-05-27
- Posted
- 2011-08-29
- Terminated
- 2013-05-23
- Reason
- Model 754/754 M Disposable MRI Ventilator Circuits are being distributed without market clearence (510k).
- Root cause
- Labeling False and Misleading
- Action
- Impact Instrumentation Inc. sent an "Urgent Product Recall" dated May 27, 2011 to all affected customers. The letter informed customers the product is not a cleared product and to return the product back to Impact Inst. for credit. A notification form is included in the letter to be return to the firm. For information on this recall contact the firms Customer Service Department at (800) 969-0750, 8:30 am to 5:00 pm EST.
- Quantity
- 492 units
- Distribution
- Nationwide Distribution; including the states of CA, FL, IL, NJ, OH, TX, UT, MN, MO, MS, OH, OR, TX, AR, and PA.
- Lot, serial or model codes
- Catalog/Code # 820-0092-00
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- cbk
- Firm FEI
- 1220908
- Firm city
- West Caldwell
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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