Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.00.04 & C.00.05 Part Number: 989803171211 Pro
FDA device recall Z-1780-2013 · posted 2013-07-20 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- IntelliVue Smart-hopping 1.4 GHz Access Point may experience unexpected signal loss of several minutes impacting wireless connectivity
- Action taken
- Philips sent an Urgent Medical Device Correction letter dated July 2013 to affected customers. The letter informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer. Philips will perform a firmware upgrade (version C.00..07 for all affected customers at no cost. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice. If you need any further information or support concerning this issue, please contact Philips Customer Support at 1-800-722-9377
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 20105 units
- Distribution
- USA Nationwide Distribution
- Date initiated
- 2013-07-08
- Date posted
- 2013-07-20
- Date terminated
- 2017-05-17
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN (K041741) | Philips Medical Systems, Inc. | 2004-07-21 |