Medtronic issues 2nd Class I recall of cranial software since 2019

Spinal Tech

Medtronic on Jan. 6 issued a Class I recall of the company's Synergy Cranial and StealthStation S7 Cranial software.

Five things to know:

1. The FDA identified this as a Class I recall, indicating the product could cause serious injury or death. The recall was issued because of potential inaccuracies with the Biopsy Depth Gauge Cycle View.

2. The company provided information to healthcare professionals with information about the potential inaccuracy during biopsy procedures Nov. 11.

3. Four complaints have been filed regarding the issue, and there have been no reported injuries or deaths.

4. The recall affects devices manufactured between May 1, 2019, and Oct. 29, 2021. Nearly 950 devices in the U.S. are affected.

5. The StealthStation system with the Synergy Cranial and StealthStation S7 Cranial software was also recalled in January 2019. That software was also recalled because of reports of inaccurate information displayed during biopsy procedures.

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