SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)
FDA device recall Z-0648-2014 · posted 2014-01-09 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware of a potential safety issue which affects all Patient Date Modules produced from April 2007 through June 2010, encompassing Fiscal Week 13, 2007 through 26, 2010 due to fluid ingress into the top cover assembly which can result in heat buildup.
- Action taken
- Consignees were sent on 12/16/2013 a GE Healthcare "Urgent Medical Device Correction" letter dated December 5, 2013. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Contact Technical Support at 1-800-558-7044 or your local Service Representative).
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 17,444 (11,418 units US, 6,026 units OUS).
- Distribution
- Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, O, NE, NV,NH, NJ, NM, NY, NC, OH, OK, OR,PA PR, RI,
- Date initiated
- 2013-12-16
- Date posted
- 2014-01-09
- Date terminated
- 2016-04-19
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (K071073) | Ge Medical Systems Information Technologies | 2007-05-11 |