Device recalls

LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.

Physio-Control, Inc. · Incorrect keypad was incorrectly installed onto a defibrillator/monitor.

Open, ClassifiedEmployee errorZ-1232-2025
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Cfres ID
211995
Product res number
Z-1232-2025
Event date initiated
2025-02-03
Event date posted
2025-02-25
Recall status
Open, Classified
Res event number
96095
Product code
MKJ
Product description
LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
Code info
Model/Catalog Number: 99507-000001 UDI-DI code: 00883873813751 Serial Number: 38289467
Firm FEI number
3015876
Recalling firm
Physio-Control, Inc.
Address 1
11811 Willows Rd Ne
City
Redmond
State
WA
Postal code
98052-2003
Additional info contact
Joyce Staggs 425-867-4597
Reason for recall
Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
Root cause description
Employee error
Product quantity
1
Distribution pattern
U.S.: WV O.U.S.: N/A
Action

On 02/03/2025, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via mail to a customer inform them that Stryker discovered that a keypad was incorrectly installed onto a LIFEPAK 20e defibrillator/monitor. There is a possibility that the incorrectly installed keypad may cause difficulty or the inability to actuate the keypad or buttons resulting in the inability to utilize the device. Additionally, there is a chance of water ingress or contamination resulting in damage to the internal machinery of the device. Customers are instructed to: 1. Immediately check your internal inventory to locate the product listed on the attached business reply form. 2. Please remove and quarantine the affected product from use. 3. To confirm receipt of this Medical Device Correction Notice and understanding of the provided information, please email the enclosed Business Reply Form (BRF) by January 31st, 2025 date, to RSRecall@Stryker.com. 4. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the return and replacement of your product(s). 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. Please ensure this letter is kept with the affected device until replacement. 6. Inform Stryker if any of the subject devices have been distributed to other organizations by contacting Stryker at: a. Device Tracking: rsdevicetracking@stryker.com b. Website: https://www.strykeremergencycare.com/service-support-overview/device-registration/ For question or concerns - contact Customer Service +1 800 442 1142 or by email RSRecall@Stryker.com.

PMA numbers
P160026
Harmonized identifiers (openFDA)
Device name
Automated External Defibrillators (Non-Wearable)
Medical specialty description
Cardiovascular
Regulation number
870.5310
Device class
3
K number
K111693, K020984, K954504, K052465, K143714, K081081, K130454, K983287, K082937, K102972, K883341, K150198, K050004, K081371, K970391, K041883, K131525, K991910, K112761, K033144, K142430, K091265, K142803, K943698, K040479, K051134, K133441, K955923, K971148, K941262, K040438, K052057, K042417, K972970, K003565, K073716, K970741, K063510, K040256, K010257 +188 more
PMA number
P160026, P160015, P180028, P160034, P160022, P210015, P190013, P170018, P190007, P200004, P200005, P160032, P200007, P160012, P160033, P160028, P160008
Registration number
3003521780, 3020460367, 3030446844, 3011823740, 3004123209, 3004035727, 3014579161, 3009886119, 1223925, 3008717264, 3027815, 3030733800, 3010703925, 2132111, 3005906887, 3002714378, 3006108746, 3003537036, 3003800159, 9681860, 3014572985, 3021559257, 3000126629, 3038259592, 1219103, 8020045, 3013517171, 3004906872, 1423662, 3026007685, 3005621729, 3021632375, 3012502601, 1720929, 3003867964, 3012607778, 3010317211, 3049791233, 3012972516, 2112020 +28 more
FEI number
3003521780, 3020460367, 3030446844, 3011823740, 3004123209, 3004035727, 3014579161, 6736, 3009886119, 3008717264, 3030733800, 3010703925, 3005906887, 3002714378, 3006108746, 3003537036, 3003800159, 3008207730, 3014572985, 3021559257, 3000126629, 3038259592, 3000215273, 3013517171, 1000148701, 3004906872, 3026007685, 3005621729, 3021632375, 3012502601, 1720929, 1000305720, 3003867964, 1000140026, 3012607778, 3010317211, 3049791233, 3012972516, 2112020, 3043226252 +28 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.