FDA Medical Device Recalls (openFDA)
Philips Visicu: eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.
- Recall number
- Z-1557-2016
- Recalling firm
- Philips Visicu
- Product
- eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.
- Status
- Terminated
- Initiated
- 2016-03-10
- Posted
- not on file
- Terminated
- 2017-10-27
- Reason
- The adherence check generates a software error. Two issues occur as a result of the software error: 1) No adherence flag is generated for that day; 2) No task is generated for the date 14 days later. An error message is generated and forwarded to operations. Subsequently, for days in which no task was generated, patient will not get a reminder on the tablet to take a measurement. If the pa
- Root cause
- Under Investigation by firm
- Action
- 1. Field Safety Notice(FSN) will be sent to all customers using eCareCoordinator v.1.3 platform. The FSN describes the problem and the circumstances in which the design defects occur and the action planned by Philips to correct the problem. The FSN will also detail the functionality change in detail. 2. A software correction will be made and released. Customers will be upgraded to eCC v.1.4. The v.1.4 is scheduled to be released on or about 8 March 2016. The defect will have been corrected and tested.
- Quantity
- 9
- Distribution
- US Distribution -- to the stated of FL, MA, MI, MS, PA, and KS.
- Lot, serial or model codes
- 453564506091 eCareCoordinator 1.3
- 510(k) numbers
- ["K141706"]
- PMA numbers
- not on file
- Product code
- DRG
- Firm FEI
- 3003063823
- Firm city
- Baltimore
- Firm state
- MD
- 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
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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