CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red (PN: 106015) (b) Rigid Adj. Arm Support, Set (PN: 106020) (c) PSR2-CR-DLR-2P Posirest-2 (PN: 106521) (d) PB2-BLR Posiboard-2 (PN: 109030) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment..
Class I - DangerousWhat Should You Do?
- Check if you have this product: Codes: M207190, M212200, M141830, M142280, M144220, M149540, M149550, M149560, M149580, M164440, M164470, M177290, M177330, M177340, M198070, M198100, M285840, M133130, M137690, M138630, M138640, M138650, M165550, M165560, M180420, M180430, M180440, M189150, M217660, M217670, M217680, M217710
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Med Tec Inc
- Reason for Recall:
- Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040 between Ocotober 2009 and July 2012 may have a height difference of approximately 17mm.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red (PN: 106015) (b) Rigid Adj. Arm Support, Set (PN: 106020) (c) PSR2-CR-DLR-2P Posirest-2 (PN: 106521) (d) PB2-BLR Posiboard-2 (PN: 109030) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment..
Product Codes/Lot Numbers:
Codes: M207190, M212200, M141830, M142280, M144220, M149540, M149550, M149560, M149580, M164440, M164470, M177290, M177330, M177340, M198070, M198100, M285840, M133130, M137690, M138630, M138640, M138650, M165550, M165560, M180420, M180430, M180440, M189150, M217660, M217670, M217680, M217710
Distribution:
Distributed in: US, MI, IL, TX, UK
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3082-2017
Related Recalls
Potential for disengagement of the Varian Style Type-S Extension during patient repositioning. The risk associated with the disengagement of the extension could be a patient fall if the patient is not supported by clinical staff.
There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.
When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal coordinates, moving the pedestal could cause the Protura software to not update with the pedestal location and buffers the pedestal movement history.