FDA Medical Device Recalls (openFDA)
Impact Instrumentation, Inc.: Model 750 24' MRI Reusable/Disposable Circuit Accessory for use with Model 750 Portable Ventilator
- Recall number
- Z-0717-2012
- Recalling firm
- Impact Instrumentation, Inc.
- Product
- Model 750 24' MRI Reusable/Disposable Circuit Accessory for use with Model 750 Portable Ventilator
- Status
- Terminated
- Initiated
- 2011-10-19
- Posted
- 2012-01-12
- Terminated
- 2013-03-11
- Reason
- Model 750 24' MRI Reusable/Disposable Circuit does not have a 510(k).
- Root cause
- PMA
- Action
- Impact sent Urgent Device Product Recall letters/return response forms dated 10/19/11 to their consignees. The letter asked customers to return the affected product listed to the address provided within 10 days of receipt of the notification letter. In order to receive proper credit for the returned product, customers should follow the instructions precisely, which includes completing and returning the Recall Tracking Form along with the affected product. If customers have no product to return, they should contact Alan Giordano at agiordano@impactii.com, to inform him of the status of the circuits.
- Quantity
- 564 units
- Distribution
- Nationwide Distribution -- VA, CA, IL, NC, and TX.
- Lot, serial or model codes
- p/n 802-1750-05, no expiration ; 802-1750-24, five years
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CAI
- 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