The Panorama HFO system has the Traceable Item Identification (12NC): 9896 030 17741-SW R 2.5.1 (shipped as R 2.5.1, upg
FDA device recall Z-1458-2011 · posted 2011-03-01 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- In the ExamCard MobiFlex the Patient Position is "Prone" which must be "Supine". The result is mislabeling of left and right side of the patient. If this is not detected by the operator there is a risk of wrong treatment or the need of additional X-RAY during treatment.
- Action taken
- Philips began sendng out the URGENT-Device Correction Notice letter dated February 5, 2010, ro all affected consignees on February 10, 2010. The consignees were advised to change the patient position from "Prone" immediately to "Supine" and store the corrected ExamCard in the hospital database if they use the ExamCard, MobiFlex dual Injection. Consignees were instructed to call Philips Healthcare Call Center at 800-722-9377 #5 (then follow prompts) and also reference "FCO 78100318" with any communication.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 82 units
- Distribution
- Nationwide Distribution including the following states: AL, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OR, SC, TN, TX, VA, VT, WI, and WV.AL, CA, DE, FL, GA, IA, IL, I
- Date initiated
- 2010-02-05
- Date posted
- 2011-03-01
- Date terminated
- 2011-08-10
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PANORAMA 1.0T (K041602) | Philips Medical Systems North America, Inc. | 2004-07-26 |