FDAClass IISeptember 25, 2024

2090 Programmers with serial number prefixes PKK0 and recall: Software Issue

2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product…

Why was 2090 Programmers with serial number prefixes PKK0 and recalled?

Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

2090 Programmers with serial number prefixes PKK0 and PKK1: a) GTIN: 00613994136480, 00613994136497, 00613994136503, 00613994136510, 00613994136527, 00613994136534, 00613994136565, 00613994136596, 00613994136619, 00613994136626, 00613994175076, 00613994175083, 00613994175090, 00613994175106, 00613994175120, 00613994175137, 00613994175144, 00613994175151, 00613994175168, 00613994175175, 00613994175182, 00613994175205, 00613994175212, 00613994175229, 00613994175236, 00613994175243, 00613994175250, 00613994175267, 00613994175281, 00613994175298, 00613994175304, 00613994175311, 00613994175328, 00613994175335, 00613994175342, 00613994175366, 00613994175373, 00613994175380, 00613994175397, 00613994175403, 00613994175410, 00613994175434, 00613994175465, 00613994175489, 00613994175540, 00613994175588, 00613994175595, 00613994203182, 00613994360922, 00613994434883, 00613994434890, 00613994434944, 00613994435002, 00613994435255, 00613994435316, 00613994580863, 00613994580894, 00613994580931, 00613994580962, 00613994581013, 00613994581051, 00613994581075, 00613994581105, 00613994581150, 00613994581167, 00613994581174, 00613994581181, 00613994581204, 00613994581211, 00613994581228, 00613994581235, 00613994581242, 00613994581549, 00613994581570, 00613994581587, 00613994581594, 00613994581624, 00643169440128, 00643169440166, 00643169440173, 00643169440197, 00643169440203, 00643169440937, 00643169537750, 00643169537774, 00643169537811, 00643169537828, 00643169537835, 00643169537842, 00643169537859, 00643169537866, 00643169537880, 00643169537910, 00643169537927, 00643169538016, 00643169629004, 00643169629011, 00643169629028, 00643169629035, 00643169629042, 00643169629066, 00721902246227, 00721902246234, 00721902246241, 00721902246265, 00721902246289, 00721902246302, 00721902246326, 00721902246333; b) GTIN: 00721902171222; c) GTIN: 00721902171079; d) GTIN: 00721902824692; e) GTIN: 00721902059100; f) GTIN: 00721902171154; g) GTIN: 00721902246357; h) GTIN: 00721902246364; i) GTIN: 00721902480201; j) GTIN: 00721902246159, 00721902246173; k) GTIN: 00721902246203; l) GTIN: 00721902841903; m) GTIN: 00721902246272; n) GTIN: 00613994127631, 00613994435354, 00613994581549, 00885074301440, 00885074310596, 00885074310633, 00885074310657, 00885074310930, 00885074312866, 00885074312873, 00885074313047, 00885074313108, 00885074313115, 00885074313139, 00885074313146, 00885074313153, 00885074313160; o) GTIN: 00885074313191; p) GTIN: 00885074313177; q) GTIN: 00885074313184; r) GTIN: 00885074314921; s) GTIN: 00885074313009; t) GTIN: 00885074357416; u) GTIN: 00885074313122

Product
2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product…
Recalling firm
Medtronic Inc.
Quantity
18788 units
Distribution
Worldwide distribution.
Recall date
September 25, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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