CapsoAccess · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

Initiated	Recall #	Class	Status	Reason	Quantity	Link basis
2020-02-26	Z-2536-2020	Class II	Terminated	Ingestible video capsule system has capsule with incorrect capture mode which will not record data when the capsule is ingested by patients. If used, there is a risk of delay of diagnosis and the patient may need to repeat the exam.Distribution: US Nationwide distribution including in the states of AZ, CA, DE, MD, NJ, NY, SC, and VA.	82	clearance family
2019-10-18	Z-1827-2020	Class II	Terminated	Capsule Endoscopy System: a defect present in the capsule window may be stressed through the production process and in the final package, which could cause the housing of the capsule to crack and leak when ingested. Fluid from the patient could leak in to the capsule, which may damage components inside the capsule and the patient data may not be retrieved; the patient may need to repeat the exam.Distribution: U.S.: CA, TX, FL, VA, PA, SC, HI, DC, NJ, UT, LA. Foreign: FR, AR, IT, UK, BE, TC, AU, CO, GM, GR, SP, SI, HR, MO, SW, EZ.	1882	clearance family
2019-07-03	Z-2073-2020	Class II	Terminated	Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.Distribution: US Nationwide distribution including in the states of FL, GA, NY, PA, and TX.	44 units	clearance family

Regulatory clearances

510(k)K192662Substantially equivalent (SESE) · 2020-02-14clearance family
510(k)K183192Substantially equivalent (SESE) · 2019-04-19clearance family
510(k)K161773Substantially equivalent (SESE) · 2016-10-21clearance family

Predicate lineage

K161773
- K151635
  - K070475
- K161535

K183192

Cited as predicate by: K192662

K192662
- K183192

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

None in the loaded window.

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