Abbott Merlin PCS 3650 pacemaker programmer software recalled for communication malfunction during threshold testing
Abbott's Merlin PCS 3650 programmer software (versions 25.0.1 through 28.7.1) may malfunction during pacing capture threshold tests on pacemakers. When this occurs, the programmer may fail to successfully send the command to stop the test.
From the FDA notice · Read the official notice ↗ · All Abbott recalls
What to do
- If you use or operate a Merlin PCS 3650 programmer, contact Abbott Medical for software guidance or updates
- Do not perform pacing capture threshold tests until you receive updated instructions from Abbott
- Contact your device representative or Abbott technical support for more information
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 11182 programs
- Illnesses reported
- None reported
- Manufactured in
- 15900 Valley View Ct, N/A, Sylmar, CA, United States
- Classification
- Class II
- Recall number
- Z-2405-2026
In the FDA's words
- Description
- Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test. Programmer Model 3650; Software Model 3330; GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region) Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: Not provided yet Affected quantity: 11182 programs
- Hazard
- Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.