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FDA (Device enforcement)Recalled 2017-11-21closedclass ii

Covidien LLC: Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Num

Is my product affected?

Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to provide a backup power s

  • UPC 20884521700861

Check against the official notice below — it lists the full affected range.

What happened

Covidien LLC is recalling rechargeable lithium-ion batteries used with Puritan Bennett 980 Series Ventilators (including pediatric-adult, neonatal, and universal models) because certain batteries contain incorrect firmware that prevents them from fully charging after installation. Approximately 15,885 affected batteries were distributed worldwide, including throughout all U.S. states and multiple countries.

The recall affects batteries with serial numbers 1349MM0001 through 1349MM0133 and beyond. The recall record does not specify what remedy or action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation.

Details from the source

Reason for recall: Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation. Distribution: Worldwide Distribution - USA (nationwide) Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, and the District of Columbia. and to the countries of : Argentina, Chile, Mexico, Panama, Canada, Australia, New Zealand, Austria, Bahrain, Belgiu Quantity: 15,885 Lot/code info: Serial Numbers: 1349MM0001 UDI: 20884521700861 1349MM0002 1349MM0003 1349MM0004 1349MM0005 1349MM0006 1349MM0007 1349MM0008 1349MM0009 1349MM0010 1349MM0011 1349MM0012 1349MM0013 1349MM0014 1349MM0015 1349MM0016 1349MM0017 1349MM0018 1349MM0019 1349MM0020 1349MM0021 1349MM0022 1349MM0023 1349MM0024 1349MM0025 1349MM0026 1349MM0027 1349MM0028 1349MM0029 1349MM0030 1349MM0031 1349MM0032 1349MM0033 1349MM0034 1349MM0035 1349MM0036 1349MM0037 1349MM0038 1349MM0039 1349MM0040 1349MM0041 1349MM0042 1349MM0043 1349MM0044 1349MM0045 1349MM0046 1349MM0047 1349MM0048 1349MM0049 1349MM0050 1349MM0051 1349MM0052 1349MM0053 1349MM0054 1349MM0055 1349MM0056 1349MM0057 1349MM0058 1349MM0059 1349MM0060 1349MM0061 1349MM0062 1349MM0063 1349MM0064 1349MM0065 1349MM0066 1349MM0067 1349MM0068 1349MM0069 1349MM0070 1349MM0071 1349MM0072 1349MM0073 1349MM0074 1349MM0075 1349MM0076 1349MM0077 1349MM0078 1349MM0079 1349MM0080 1349MM0081 1349MM0082 1349MM0083 1349MM0084 1349MM0085 1349MM0086 1349MM0087 1349MM0088 1349MM0089 1349MM0090 1349MM0091 1349MM0092 1349MM0093 1349MM0094 1349MM0095 1349MM0096 1349MM0097 1349MM0098 1349MM0099 1349MM0100 1349MM0101 1349MM0102 1349MM0103 1349MM0104 1349MM0105 1349MM0106 1349MM0107 1349MM0108 1349MM0109 1349MM0110 1349MM0111 1349MM0112 1349MM0113 1349MM0114 1349MM0115 1349MM0116 1349MM0117 1349MM0118 1349MM0119 1349MM0120 1349MM0121 1349MM0122 1349MM0123 1349MM0124 1349MM0125 1349MM0126 1349MM0127 1349MM0128 1349MM0129 1349MM0130 1349MM0131 1349MM0132 1349MM0133 1

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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