Philips Intellivue Patient Monitor Model MP70 (M8007A)
FDA device recall Z-2202-2010 · posted 2010-08-10 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- Additional Instruction for Use for Intellivue MP60/MP70 to prevent monitors from becoming loose and detaching from the mounting arm.
- Action taken
- Philips issued on 6/28/10 an Urgent Medical Device Correction notification/Field Safety Notice. Included with the Urgent Medical Device Correction notification/Field Safety Notice is an updated instructions for use and service instructions for these monitors that remind users to follow the mounting arm manufacturer's instructions for use when repositioning the monitor and instructing them to perform a periodic check that the monitor is not loose on the arm.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 82,019 units
- Distribution
- Worldwide distribution: USA, Canada, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, Bosnia, BRAZIL, BULGARIA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REP
- Date initiated
- 2010-06-28
- Date posted
- 2010-08-10
- Date terminated
- 2017-02-15
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTELLIVUE PATIENT MONITOR (K093268) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010-05-11 |