The product's marketing brochure states: "1.5T coils and accessories...Philips Achieva and Intera 1.5T MR systems". The
FDA device recall Z-0469-2011 · posted 2010-11-26 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Combined use of the Synergy Flex-M / Shoulder Coil 1.5T increases the chance of RF interaction and heating up of the coil. This may result in possible burns of the patient.
- Action taken
- Philips issued URGENT-Field Safety Notice letters dated May 1, 2009 and October 14, 2009 to their consignees. The letter informed customers that the firm will replace the "old" Flex M/Shoulder Coils with a new Flex-M coil. Consignees could contact Philips Healthcare Call Center at 800-722-9377, #5, #3, #1 and reference FCO 78100290 for any questions.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 389 units
- Distribution
- Nationwide Distribution: in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN
- Date initiated
- 2009-05-01
- Date posted
- 2010-11-26
- Date terminated
- 2011-01-06
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTERA-SENSATION FAMILY (K031815) | Philips Medical Systems | 2003-09-10 |
| GYROSCAN INTERA (R7.5) (K001796) | Philips Medical Systems North America, Inc. | 2000-09-06 |