Recall Z-1339-2019
Siemens Medical Solutions USA, Inc · initiated April 9, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
Codes / lots: Serial Numbers 138260 138221 138259 138250 138268 138266 124286 125245 148402 148401 148384 148390 147249 148393 148411 148400 148358 148361 148397 148392 148382 148363 148375 155237 155203 155226 155227 155235 131235
Reason for recall
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
FDA-determined cause: Software design
Action taken
On April 9, 2019, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that ARTIS systems equipped with certain motor control units may encounter with hardware failure, and planned procedures may need to be terminated and performed on an alternative x-ray system. The firm stated their service organization would contact customers shortly to arrange a date to perform a software update to correct the issue. For an earlier appointment or if you have any questions, you may contact the firm at 1-800-888-7436. Customers were asked to promptly notify and instruct all staff at the organization who need to be aware of the notice. Additionally, if you further distributed the product, please identify your customers and notify them at once of this recall.
Details
- Recall number
- Z-1339-2019
- Initiated
- April 9, 2019
- Terminated
- April 23, 2020
- Product code
- IZI – System, X-Ray, Angiographic
- Quantity
- 459 (116 US)
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL,AR, AZ, CA, FL, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NV, NY, OH, OK, OR, PA, RI, SC, SD, TX, UT, VA , WA WI and WV. and Foreign countries.
- Recalling firm
- Siemens Medical Solutions USA, Inc, Malvern, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1340-2019 Class II | Artis Zeego (material 10280959) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a…In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has… | 04/09/2019Terminated |
| Z-1341-2019 Class II | Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/…In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has… | 04/09/2019Terminated |
| Z-1342-2019 Class II | Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/…In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has… | 04/09/2019Terminated |