Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software…

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• Brand NameGuardian 2
• System Product NameGuardian System 2
• Controller Model/Catalog NumberGS-2.5-C
• Software Version2.5.4-69 (Fix)

Lot codes and dates

• Model/Catalog NumberGS-2.5-C
• Software Version2.5.4-69 (Fix)
• UDI-DI(01)00860001236453
• Serial Numbers

  1,142 of 1,142 codes

  • 2007.01
  • 2037.01
  • 2070.01
  • 2074.01
  • 2160.01
  • 2186.01
  • 2191.01
  • 2197.01
  • 2200.01
  • 2203.01
  • 2236.01
  • 2259.01
  • 2286.01
  • 2299.01
  • 2301.01
  • 2303.01
  • 2449.01
  • 2505.01
  • 2524.01
  • 2557.01
  • 2558.01
  • 2576.2.2
  • 2588.2.2.3
  • 2591.2.2.3
  • 2606.2.2.3
  • 2615.2.2.3
  • 2630.2.2.3
  • 2645.2.2.3
  • 2655.2.2.3
  • 2658.2.2.3
  • 2666.2.2
  • 2706.2.2.3
  • 2737.2.2.3
  • 2741.2.2.3
  • 2750.2.2.3
  • 2827.2.2.3
  • 2836.2.2.3
  • 2846.2.2.3
  • 2873.2.2
  • 2874.2.2
  • 2875.2.2.3
  • 2898.2.2
  • 2901.2.2.3
  • 2902.2.2
  • 2903.2.2
  • 2913.2.2.3
  • 2919.2.2.3
  • 2959.2.2.3
  • 2960.2.2.3
  • 2965.2.2.3
  • 2968.2.2.3
  • 2976.2.2.3
  • 2978.2.2.3
  • 3001.2.2.3
  • 3013.2.2.3
  • 3017.2.2.3
  • 3034.2.2.3
  • 3048.2.2.3
  • 3055.2.2.3
  • 2571.2.2

  Show all 1,142 codes

Amount recalled

1142 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

• Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/

Where it was sold

• Nationwide
• CT
• FL
• IL
• PA
• TX

Why it was recalled

A software update corrected an issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.

This product could cause temporary or reversible health problems — stop using it.