| Date Initiated by Firm | November 15, 2018 |
|---|
| Create Date | December 14, 2018 |
|---|
| Recall Status1 |
Terminated 3 on September 20, 2024 |
| Recall Number | Z-0614-2019 |
|---|
| Recall Event ID |
81527 |
| 510(K)Number | K101571 |
|---|
| Product Classification |
Computer, diagnostic, programmable - Product Code DQK
|
| Product | Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081 |
|---|
| Code Information |
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Recalling Firm/
Manufacturer |
Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
|
| For Additional Information Contact | Philips Customer Services
800-722-9377 |
|---|
Manufacturer Reason
for Recall | There are 3 issues:
1) Under certain conditions, real time waveforms may not be accurately plotted or displayed.
2) The oxygen saturation (SpO2) numeric value displayed on the device may freeze.
3) In auto cycle mode, if the NIBP communication is lost, the pump would not cycle and the non-invasive blood pressure (NIBP) numeric value displayed on the device would not update. |
|---|
FDA Determined
Cause 2 | Software Design Change |
|---|
| Action | The firm initiated the recall on X by letter. The letter explained the issues, potential risk, and provided workarounds for the consignee to use until the new software is ready for release. |
|---|
| Quantity in Commerce | 651 units |
|---|
| Distribution | worldwide |
|---|
| Total Product Life Cycle | TPLC Device Report |
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|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = DQK
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