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
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.
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