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

Recall Z-2053-2014 — SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400254 and the Arm part number in the kit

U.S. FDA — Device Enforcement · United States · 2014-03-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2053-2014
Date of alert: 2014-03-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stryker Communications
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 0682400254

Reported risk: During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.

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

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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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