Accelerated Care Plus Corporation Recalls
Showing 1-2 of 2 recalls
Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health
On 08/25/2021, Medical Device Recall notices were mailed and emailed to customers who were asked to take the following actions: Immediately stop use of all Eco-Med products. - Destroy and render unusable all affected products that you received from ACPL, by disposing the gel along with your general medical waste. - Carefully read the Recall Notice and follow the instructions, including completing the Eco-Med Product Recall Response Form indicating that you have read the recall notice and will take appropriate action including documenting the quantity of product in inventory and the quantity destroyed. - If you have further distributed this product, please identify your customers, and notify them at once of this product recall by sharing this recall notification letter. Customers with additional questions or concerns can call Customer Support at 800.350.1100.
Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufactured by Medica Medizintechnik GmbH, Hochdorf, Germany. The product is indicated for powered exercise equipment intended for medical purposes.
An anomaly in the firmware that may cause Omnicycle Elite to operate at a speed other than what was previously set when in reverse mode.
Letters were issued on June 12, 2013 that included a memory stick with self loading software so consumers can update the device. Letters were sent by trackable method. Customers with questions or concerns should call Customer Support at 800-350-1100.