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U.S. Department of Health and Human Services

Class 2 Device Recall Accelerator APS

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  Class 2 Device Recall Accelerator APS see related information
Date Initiated by Firm September 07, 2018
Create Date September 26, 2019
Recall Status1 Terminated 3 on February 02, 2021
Recall Number Z-2755-2019
Recall Event ID 83651
510(K)Number K093318  
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
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
Recalling Firm/
Manufacturer		 Abbott Laboratories, Inc
1921 Hurd Dr
Irving TX 75038-4313
For Additional Information Contact Abbott Customer Service
877-422-2688
Manufacturer 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.
FDA Determined
Cause 2		 Component change control
Action On September 7, 2018, Abbott sent all affected consignees a "Product Correction Urgent - Immediate Action required" letter along with an "Attachment A" containing serial numbers. The letter informed consignees of the following: 1.Please be aware that personnel fitted with a pacemaker/implanted heart defibrillator must not handle or work on these modules at distances less than 200 mm even if the warning label is missing. 2. Your Abbott representative will be contacting you to schedule time to place a new hazard label on the APS modules. In the interim, please remove the last page of this letter and affix a copy of the label on the cover of these modules until the official pacemaker label is available. 3.Please review the attached Errata Sheet and save it with the Operations Manual for future reference regarding the safety distance required for pacemakers/implanted heart defibrillator. 4. Please retain this letter for your laboratory records. 5. If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 1877 4ABBOTT (available 24 hours a day, 7 days a week). 6. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online at (http://www.fda.gov/MedWatch/report.htm), by mail (http://www.fda.gov/MedWatch/getforms.htm), by phone (18003321088), or by fax (1800FDA 0178).
Quantity in Commerce 159 devices
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JQP and Original Applicant = ABBOTT LABORATORIES
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