Z-2755-2019 Class II Terminated
Recalled by Abbott Laboratories, Inc
— Irving, TX
FDA device recall Z-2755-2019 was initiated by Abbott Laboratories, Inc on Sep 7, 2018 and is designated Class II. Reason for recall: The firm identified customer sites where modules which the safety pacemaker label is missing. Information regarding the label included in the Operations Manual has been updated to specify: 1) the risk… The recall status is terminated (terminated Feb 2, 2021). Affected quantity: 159 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 2, 2019
- Initiation Date
- Sep 7, 2018
- Termination Date
- Feb 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 159 devices
Product Description
APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
Reason for Recall
The firm identified customer sites where modules which the safety pacemaker label is missing. Information regarding the label included in the Operations Manual has been updated to specify: 1) the risk of malfunction applies to anyone with a pacemaker who may work on these modules; 2) the minimum safety distance has increased to 200 mm (7.87") from transport mechanisms. Any person with a pacemaker must not get closer than this distance from modules axes.
Distribution Pattern
US: TX, VA, AZ, NV, MA, LA, MN, PA, SC, NJ, NY, CA, IL, IN, WA, FL, TN, PA, KS, ND, NC, CT OUS: Argentina, Australia, Belgium, Canada, China, Denmark, France, Greece, Hong Kong, Ireland, Italy, New Zealand, Norway, Oman, Pakistan, Philippines, Portugal, Russia, Saudi Arabia, Singapore, Spain, Taiwan, Turkey, UAE, UK, Venezuela
Code Information
All Lot Numbers ABT018 ABT070 ABT107 ABT135 ABT019 ABT074 ABT108 ABT136 ABT023 ABT075 ABT109 ABT137 ABT024 ABT077 ABT110 ABT138 ABT026 ABT078 ABT111 ABT139 ABT027 ABT081 ABT112 ABT140 ABT028 ABT082 ABT113 ABT142 ABT034 ABT083 ABT114 ABT143 ABT036 ABT084 ABT116 ABT144 ABT037 ABT086 ABT117 ABT145 ABT041 ABT088 ABT118 ABT146 ABT042 ABT089 ABT119 ABT147 ABT047 ABT091 ABT120 ABT149 ABT049 ABT092 ABT121 ABT150 ABT050 ABT093 ABT122 ABT151 ABT051 ABT094 ABT123 ABT152 ABT054 ABT096 ABT124 ABT153 ABT058 ABT097 ABT125 ABT154 ABT059 ABT098 ABT126 ABT156 ABT062 ABT099 ABT127 ABT157 ABT063 ABT100 ABT128 ABT158 ABT065 ABT101 ABT129 ABT159 ABT066 ABT102 ABT130 ABT067 ABT104 ABT131 ABT068 ABT105 ABT132 ABT069 ABT106 ABT133
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2755-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026
These dates say when openFDA published the data file and when RegDataLab last loaded it.