Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2081-2019 — GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.

U.S. FDA — Device Enforcement · United States · 2019-07-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2081-2019
Date of alert: 2019-07-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Xcision Medical Systems, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00850002615005

Reported risk: One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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