St Jude Medical, Cardiac Rhythm Management Division: Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label

Is my product affected?

Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to

• UPC 05414734509725
• UPC 05415067027320

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

What happened

St. Jude Medical is recalling Confirm Rx Insertable Cardiac Monitor (ICM) devices used with Merlin PCS Programmer software due to a memory corruption issue that caused the devices to inappropriately display a low battery indicator. Approximately 2,906 affected ICMs were distributed worldwide, including throughout the United States and in numerous countries including Canada, Australia, France, Germany, Japan, and others. The recalled devices are identified by specific serial numbers and use Merlin PCS Programmer Software version V24.0.1 rev 1.

The record does not specify a remedy or recommended action for affected consumers.

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

Hazard

Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.

Details from the source

Reason for recall: Devices inappropriately displayed a low battery indicator determined to be due to memory corruption. Distribution: Worldwide distribution - US Nationwide. distribution. There was also government/military distribution. Countries of Canada, Aruba, Australia, Belgium, Brazil, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Luxembourg, Martinique, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pol Quantity: 2,906 impacted ICMs Lot/code info: Merlin PCS Programmer Software, V24.0.1 rev 1, UDI 05414734509725. Confirm Rx ICM, UDI 05415067027320, US serial numbers: 3161783 3165630 3169553 3172363 3175335 3175336 3175337 3175349 3175356 3175377 3175378 3175385 3175393 3175394 3175395 3175399 3175402 3178901 3178907 3178909 3178916 3178919 3178921 3178930 3178937 3178943 3178945 3178946 3178951 3178954 3178962 3178969 3178974 3178981 3178995 3179005 3179024 3179103 3179123 3179149 3179177 3179199 3179260 3179443 3179452 3179520 3179533 3179539 3179542 3179543 3179570 3179583 3179589 3179595 3179603 3179609 3179850 3179851 3179921 3179929 3179953 3179965 3179972 3179988 3179991 3179997 3180019 3180030 3180038 3180309 3180326 3180333 3180411 3180420 3180421 3180424 3180578 3180604 3180607 3180608 3180617 3180661 3180675 3180679 3180692 3180695 3180704 3180969 3181038 3181066 3181067 3181168 3181171 3181174 3181175 3181199 3181203 3181217 3181226 3181233 3181246 3181248 3181267 3181494 3181655 3181683 3181688 3181742 3181744 3181745 3181776 3182193 3182217 3182228 3182229 3182230 3182248 3182262 3182300 3182523 3182585 3182594 3182617 3182632 3182858 3182863 3182885 3182890 3182939 3182950 3182965 3182972 3182989 3183002 3183003 3183005 3183043 3183105 3183112 3183270 3183281 3183294 3183307 3183321 3183332 3183638 3183715 3183739 3183777 3183782 3183821 3183842 3183847 3183915 3183961 3183979 3183987 3183988 3184008 3184076 3184142 3184160 3184192 3184225 3184238 3184239 3184251 3184259 3184297 3184307 3184321 3184389 31

Source

Official record: FDA (Device enforcement) ↗

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

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