Z-0717-2012

Model 750 24' MRI Reusable/Disposable Circuit Accessory for use with Model 750 Portable Ventilator

Name: Z-0717-2012 Model 750 24' MRI Reusable/Disposable Circuit Accessory for use with Model 750 Portable Ventilator
Creator: Impact Instrumentation, Inc.
Published: 2011-10-19
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2011-10-19 / Terminated

FDA source

Impact Instrumentation, Inc. began a recall of Model 750 24' MRI Reusable/Disposable Circuit Accessory for use with Model 750 Portable Ventilator on 2011-10-19. The reason FDA records is "Model 750 24' MRI Reusable/Disposable Circuit does not have a 510(k)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0717-2012
Status: Terminated
Initiated: 2011-10-19
Posted: 2012-01-12
Terminated: 2013-03-11
Recalling firm: ZOLL Medical Corporation
Product: Model 750 24' MRI Reusable/Disposable Circuit Accessory for use with Model 750 Portable Ventilator
Product code: CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
Reason for recall: Model 750 24' MRI Reusable/Disposable Circuit does not have a 510(k).
FDA 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 [email protected], to inform him of the status of the circuits.
Quantity in commerce: 564 units
Distribution: Nationwide Distribution -- VA, CA, IL, NC, and TX.
Product codes and lots: p/n 802-1750-05, no expiration ; 802-1750-24, five years

Product code CAI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)