FDA Device recall Z-2320-2018
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981
- FDA Device
- Class II
- terminated
- Published 2018-07-04
On 2018-07-04 the FDA classified a Class II recall of Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981 by St Jude Medical, citing the firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2320-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-16 |
| Published | 2018-07-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | St Jude Medical |
| Distribution | US |
Product
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
Reason
The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
Identifiers
| code_info | Serial #: 1088287 1086945 791534 803774 1088281 1238556 1238547 1205582 1238546 1238550 1238549 1238555 12…Serial #: 1088287 1086945 791534 803774 1088281 1238556 1238547 1205582 1238546 1238550 1238549 1238555 1225890 1241948 1238542 1208712 1238553 1203728 1242808 1241596 1204938 1241585 1241601 1243063 1236460 1224005 1241592 1242398 1242701 1238608 1236436 1238603 1243251 1238600 1223990 1239853 1189142 1208713 1205609 1238601 1223995 1239852 1239854 1239848 1252018 1252033 1239856 1238548 1238544 1205578 1205607 1238605 1238604 1223980 1197908 1204945 1236435 1164056 1220447 1203416 1205466 1220445 1220458 1203410 1239173 1236889 1080885 1080870 798885 1046083 1080886 1080884 1083520 791593 1033647 791595 791526 837528 821990 1236904 1209764 1232792 1252023 1197906 1197914 1197913 1197910 1199394 1086922 1064897 1064898 1033645 803775 803815 803762 803789 798875 1208046 803796 798928 803806 803760 798909 798913 803794 803803 803807 803802 803808 803813 798935 803793 803763 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2320-2018%22
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