Z-1819-2012Class II

US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling...

Name: Z-1819-2012 US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling...
Creator: Non-Invasive Monitoring Systems, Inc.
Published: 2012-05-07
License: https://open.fda.gov/license/

Non-Invasive Monitoring Systems, Inc. / initiated 2012-05-07 / Terminated / root cause: labeling and UDI

FDA source

Non-Invasive Monitoring Systems, Inc. began a recall of US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general... on 2012-05-07. FDA classified it as Class II and gives the reason as "Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1819-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-07
Posted: 2012-06-18
Terminated: 2012-07-16
Recalling firm: Non-Invasive Monitoring Systems, Inc.
Product: US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Ever-Rest US Brochure US-001 Rev A. Brochure: "***AT acceleration THERAPEUTICS***At Non-Invasive Medical Solutions (NIMS) we pride ourselves on being at the forefront of developing drug free wellness solutions coupled with accredited peer-reviewed clinical research...***Whole Body Periodic Acceleration (WBPA) therapy has been demonstrated to naturally activate the release of beneficial mediators like Nitric Oxide (NO) throughout the vasculature.***Nitric Oxide [NO] supports the functioning of endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow through arteries and veins. With age arterial production and availability of Nitric oxide declines.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***[email protected] www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***US-001 Rev A***" Printed marketing brochure
Product code: IRO Vibrator, Therapeutic
Reason for recall: Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: NiMS sent an Urgent Promotional Material Recall letter dated May 29, 2012, to all affected customers. NIMS contacted the 18 facilities by phone starting on May 29, 2012 and sent the 73 end users letters dated May 29, 2012. NiMS instructed customers to immediately examine their inventory and quarantine any of the US-001 or USA-002 brochures. If customers further distributed brochures customers were instructed to notify their customers at once by including a copy of the recall notification letter. Customers were requested to destroy all Exer-Rest promotional materials. For any questions customers were instructed to call 305-575-4204. For questions regarding this recall call 305-575-4201.
Quantity in commerce: US-001 Rev A brochure: 3665
Distribution: Nationwide Distribution
Product codes and lots: Brochure US-001 Rev A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1819-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1819-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-18
Z-1820-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-18

Product code IRO

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)