FDA Medical Device Recalls (openFDA)
Invivo Corporation: Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
- Recall number
- Z-3192-2018
- Recalling firm
- Invivo Corporation
- Product
- Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
- Status
- Terminated
- Initiated
- 2018-08-03
- Posted
- not on file
- Terminated
- 2021-07-15
- Reason
- Released with an incorrect, older firmware version installed. May result in intermittent loss of ECG monitoring, inaccurate ECG amplitude display and or auxiliary output, and inaccurate heart rate (HR) displayed due to QRS detection fault.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- Philips is asking customers to follow the Action to be Taken by Customer/User section of the August 3, 2018, Field Safety Notice: The Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Philips will replace all affected devices. Users should discontinue use of affected devices immediately. A Philips representative will contact you regarding your affected device.
- Quantity
- 38
- Distribution
- Distribution in the Netherlands
- Lot, serial or model codes
- System Serial Numbers: US1814000001, US1814000002, US1814000003, US1814000004, US1814000006, US1814000007, US1814000008, US1814000011, US1814000012, US1814000013, US1814000014, US1814000016, US1814000017, US1814000018, US1814000019, US1814000020, US1814000022, US1814000023, US1814000024, US1814000027, US1814000028, US1814000030, US1814000031, US1814000032, US1814000033, US1814000034, US1814000037, US1814000044, US1814000046, US1814000050, US1814000053, US1814000062, US1814000066, US1814000068,and US1814000072
- 510(k) numbers
- ["K101571"]
- PMA numbers
- not on file
- Product code
- MWI
- Firm FEI
- 1051786
- Firm city
- Orlando
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28