Recall Z-1820-2012 ยท IRO Vibrator, Therapeutic
Non-Invasive Monitoring Systems, Inc.
USA-002 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. Brochure: "EXER-REST***A patented, FDA registered, Acceleration Therapeutics device delivering Whole Body Periodic Acceleration to the user for symptomatic relief of a
| Date | Jun 18, 2012 (initiated May 7, 2012) |
| Status | Terminated |
| Reason | Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims. |
| 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 cu |
| Quantity | USA-002 Rev A brochure: 91 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.