Recall Z-2755-2019 ยท JQP Calculator/Data Processing Module, For Clinical Use
Abbott Laboratories, Inc
APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
| Date | Sep 7, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 lett |
| Quantity | 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, Taiwa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093318 | ACCELERATOR APS Abbott Laboratories, Feb 19, 2010 |