Synergy Cranial & Stealthstation S7 Recall
The StealthStation System, with Synergy Cranial software or StealthStation S7 Cranial software, helps to locate the anatomical structures in neurosurgical operations. According to a recall announcement from the U.S. Food and Drug Administration, the FDA has issued a Class I recall for Synergy Cranial and Stealthstation S7 Cranial Software. A Class I recall is the most severe type of recall because the product or device can injure or kill its user. The recalled StealthStation System, with Synergy Cranial software or StealthStation S7 Cranial software, was distributed in the United States from May 1, 2019, until October 29, 2021. The total number of units recalled in the United States is 943.
When the user faces a software problem involving the graphical Biopsy Depth Gauge and the device losing synchronization with other navigation views, there may be;
- a need for an additional surgical procedure,
- tissue injury,
- an aborted procedure,
- life-threatening injury,
- brain hemorrhages,
- permanent neurological injuries, and
- death.
There are four complaints on record concerning the device’s software defect.
On November 11, 2021, Medtronic furnished health care providers with information concerning inaccuracy issues during biopsy procedures using the StealthStation i7 and StealthStation S7 Biopsy Depth Gauge feature.
Customers are asked to contact Medtronic Technical Services and discontinue the use of the devices until speaking with Medtronic. Medtronic will also provide an instructional placard and a warning to be applied to the recalled StealthStation System. The notifications have been communicated to all physician users.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Did you or a loved one suffer harm from a defective product? Parker Waichman LLP helps those who have suffered injuries after using defective products receive full monetary compensation. Trust your case with our product liability lawsuit lawyers. For a free consultation, contact our law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
New York | Brooklyn | Queens | Long Island | New Jersey | Florida
Call us at: 1-800-YOURLAWYER (800-968-7529) | Schedule your free consultation
